Neuralink — Elon Musk’s neurotechnology startup company — announced on Tuesday that recruitment is open to implant a wireless brain-computer interface in its first in-human clinical trial.
Company officials describe the PRIME Study — short for Precise Robotically Implanted Brain-Computer Interface — as a groundbreaking investigational medical device trial designed to evaluate the safety and assess the functionality of an implant and surgical robot for people with severe degenerative diseases, such as amyotrophic lateral sclerosis (ALS), to control external devices with their thoughts.
“During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention,” the company <a href="https://neuralink.com/blog/first-clinical-trial-open-for-recruitment/" target="_blank" rel="noopener">announced</a>. “Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention.”
“The initial goal of our [Brain-Computer Interface] is to grant people the ability to control a computer cursor or keyboard using their thoughts alone,” the company added.
Applicants with quadriplegia due to cervical spinal cord injury or ALS may qualify for the trial, officials said.
Musk has touted that over the years, the experimental brain-chip implant could treat neurological disorders such as paralysis and blindness by bridging signals between existing neurons and allowing humans to save and replay memories, <a href="https://www.dailywire.com/news/elon-musks-neuralink-startup-receives-fda-approval-for-first-in-human-brain-chip-implant-clinical-study" target="_blank" rel="noopener">saying</a> that “the future is going to be weird.”
Musk <a href="https://www.cnbc.com/2023/05/25/elon-musks-neuralink-gets-fda-approval-for-in-human-study.html" target="_blank" rel="noopener">reportedly</a> said at a “show and tell” recruitment event late last year that he would likely implant himself with the neurotechnology.
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“You could have a Neuralink device implanted right now, and you wouldn’t even know,” Musk said at the time. “In fact, in one of these demos, I will.”
The company received approval from the U.S. Food and Drug Administration (FDA) in May to launch its first-in-human clinical study.
Neuralink received FDA breakthrough designation for its technology three years ago, and Musk repeatedly claimed that human trials would begin immediately. However, the company had its application rejected in early 2022 by the FDA over safety concerns.
Seven current and former FDA employees <a href="https://www.reuters.com/investigates/special-report/neuralink-musk-fda/" target="_blank" rel="noopener">told</a> Reuters earlier this year that the agency’s major safety concerns involved “the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue.”
“We want to be extremely careful and certain that it will work well before putting a device into a human,” Musk said, according to Reuters. “The progress at first, particularly as it applies to humans, will seem perhaps agonizingly slow, but we are doing all of the things to bring it to scale in parallel. So, in theory, progress should be exponential.”
The approval comes as U.S. lawmakers requested that regulators <a href="https://www.reuters.com/world/us/us-lawmakers-seek-probe-how-elon-musks-brain-chip-venture-oversees-animal-2023-05-12/" target="_blank" rel="noopener">investigate</a> how the company has conducted animal testing and if those trials were rushed or resulted in failed experiments.
Neuralink has also faced other federal investigations, including from the USDA’s Inspector General over concerns of violating the Animal Welfare Act and the U.S. Department of Transportation over accusations over the movement of hazardous pathogens.

Neuralink Illustrations

Musk’s Neuralink Opens Recruitment For First In-Human Brain Chip Clinical Trial

Musk's Neuralink Opens Recruitment For First In-Human Brain Chip Clinical Trial

Artificial Intelligence

Brain

Elon Musk

Technology

U.S.

When the government suddenly announces a recall, or even talks about pulling a product from the shelves, it&#8217;s normal to assume that some unexpected defect has recently been discovered. Maybe the feds have noticed that a car&#8217;s airbags don&#8217;t deploy during a crash, or that a certain brand of fish tank is prone to spontaneous implosion. Whatever the case, you&#8217;re inclined to think that some new information has come to light that necessitates the recall. And in most circumstances that&#8217;s true.
But there is one industry —Big Pharma — that has consistently been the exception to this rule. This is an industry that happens to enjoy a lot of special treatment from the federal government, including immunity from lawsuits. In the pharmaceutical industry, a recall doesn&#8217;t necessarily mean that some catastrophic defect has just been identified. Instead, it often means that there&#8217;s been a known problem for a very long time — one that&#8217;s been deliberately hidden from the public, until finally it&#8217;s impossible to deny any longer. After COVID, most of the country realizes that this kind of thing can happen. What they might not realize, because there&#8217;s a mountain of propaganda designed to hide this fact, is how common this is.
Here&#8217;s the latest example. Right now the pharmaceutical industry is debating whether to issue one of the biggest recalls in modern history. The recall would affect a wide array of over-the-counter cold medicines, including some products bearing the brand names Mucinex, Tylenol, Sudafed, NyQuil, and Benadryl. The reason? According to the government, these products <a href="https://www.nytimes.com/2023/09/12/health/cold-medicine-decongestant-fda.html#:~:text=996-,A%20Decongestant%20in%20Cold%20Medicines%20Doesn%27t%20Work%20at%20All,time%20to%20substitute%20other%20ingredients." target="_blank" rel="noopener">don&#8217;t work</a>. At all. 
To be clear, as we&#8217;ll explain in a second, some Benadryl and Sudafed products still work, according to the government. We&#8217;re talking about a certain but very popular subset of these over-the-counter products that use a specific ingredient. At the same time, if you&#8217;re one of the hundreds of millions of people who have consumed these products over the past decade, this is a big headline. You paid money for a product that you thought worked, on assurances from the government and Big Pharma. You then ingested this product, based on those assurances. And now you&#8217;re being told that these pills had all the effectiveness of eating a cookie and drinking some warm milk.
One of the first questions you&#8217;d think to ask, under these circumstances, is when exactly the regulators and the pharmaceutical companies figured out that these products are completely ineffective. If you listen to most news reports on this subject, you&#8217;ll be left with the impression that some new information came out. That impression would be completely wrong, but it&#8217;s what they&#8217;re presenting. Here, for example, is CBS News:
<iframe loading="lazy" title="FDA committee says nasal decongestants don&#039;t work" width="500" height="281" src="https://www.youtube.com/embed/57RtIN3CLqw?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
What&#8217;s left unmentioned in that report is that this significant alleged defect in these drugs — the fact that they don&#8217;t do anything — has been widely known for years. It&#8217;s not new information. Nearly a decade ago, in 2015, researchers at the University of Florida said they <a href="https://pharmacy.ufl.edu/2015/10/14/uf-researchers-ask-fda-to-remove-non-prescription-decongestant-from-the-market/" target="_blank" rel="noopener">found</a> conclusive evidence that many non-prescription decongestants didn&#8217;t work. “Scientific evidence continues to show that the most popular products on the market containing phenylephrine are ineffective.&#8221; (Phenylephrine, to be clear, is used in certain drugs like over-the-counter Sudafed. It&#8217;s not used in the brand of Sudafed you have to get from the pharmacist.)
The researchers continued: &#8220;We think the evidence supports that phenylephrine’s status as a safe and effective over-the-counter product should be changed. We are looking out for the consumer, and he or she needs to know that science says that oral phenylephrine does not work for the majority of people.”
<h4><a href="https://www.dailywire.com/episode/ep-1222-the-matt-walsh-show" target="_blank" rel="noopener">WATCH: The Matt Walsh Show</a></h4>
This was back during the Obama administration. The findings raised a lot of uncomfortable questions, such as: Why would the FDA approve a drug that&#8217;s effectively a placebo? Why were regulators still allowing Big Pharma to sell it? Why were people continuing to buy drugs that didn&#8217;t do anything? And where are the prosecutors? Isn&#8217;t it fraud to advertise products that don&#8217;t work? Shouldn’t there be penalties for making billions of dollars off of something that doesn’t do what it’s supposed to do?
By refusing to do anything about phenylephrine, the federal government dodged all of these questions. They also helped cover up their role in causing the problem in the first place. You rarely hear this discussed, but the supposedly useless ingredient in question, phenylephrine, wasn&#8217;t always used in medications like Sudafed. Twenty years ago, the key ingredient in the most popular form of Sudafed was a very different decongestant called pseudoephedrine. This ingredient, we can be reasonably confident, actually works.
But in 2006, the federal government made it a lot harder to get &#8220;real Sudafed&#8221; with this ingredient. Congress passed a law effectively requiring people to undergo background checks before they could walk out of the store with it. &#8220;Real Sudafed&#8221; was no longer an over-the-counter medication. The justification for this restriction, ostensibly, was stopping people from using the ingredient to make meth. We&#8217;ll be taking a lot of dangerous drug kingpins off the streets, they told us.
Once Congress passed that law, Big Pharma needed an alternative. Most customers don&#8217;t want to wait in line for a pharmacist every time they need a decongestant. So they&#8217;ll leave the CVS without making a purchase. So very quickly big pharma came out with a new form of Sudafed using a different ingredient, called phenylephrine. Big Pharma, and the federal government, told us it was the best of both worlds. This new form of Sudafed can&#8217;t be used to make meth. At the same time, we were assured, it&#8217;s just as effective as real Sudafed.
Shortly after that law was passed, there were reasons to doubt the narrative that the government was pushing. For one thing, because of all these changes, a lot of innocent people were <a href="https://reason.com/2006/12/24/man-arrested-for-allergies/" target="_blank" rel="noopener">arrested</a> for no reason. One of them was named Tim Naveau. He was charged with a federal crime for buying too much Claritin. He wanted to get some extra pills for his son, who was going away to camp. In response, local officials arrested the man. They didn&#8217;t care that he wasn&#8217;t making meth. They charged him anyway. They said he was collateral damage in the larger meth war, which this legislation would help the federal government win.
Nearly two decades later, we learn that nothing we were told turned out to be true. For one thing, meth has never been easier, or cheaper, to obtain in this country. It&#8217;s not coming from domestic meth labs, for the most part. Instead it&#8217;s coming from Mexico, across a border that the federal government has deliberately left open. And on top of that, according to the government, the substitute Sudafed and related drugs were not effective, as we were promised. It&#8217;s useless. The new narrative is that Big Pharma made billions of dollars every year selling products that did not work. They knew it. The federal government let them do it.
Why are they telling us now? Is anything they&#8217;re telling us true? That&#8217;s a question we can&#8217;t answer, because both Big Pharma and federal regulators have lied so routinely, so consistently, that there&#8217;s no reason to take anything they say at face value. If recent history is any indication, it&#8217;s probably not a good sign. Normally when the federal government says a drug doesn&#8217;t work, there&#8217;s two possibilities.
The first possibility is that they&#8217;re trying to drive up sales of some other drug. We saw that during COVID: &#8220;Don&#8217;t take that therapeutic; it&#8217;s horse tranquilizer. Take our shot instead.&#8221; In the case of these decongestants, there&#8217;s long been a push to require prescriptions. In various states, activists and politicians have said it&#8217;s not enough to hide these decongestants behind the counter, and to track their sale. They say it&#8217;s necessary to require people to get a prescription first. This has been going on for a while. Here&#8217;s one report in Indiana from a decade ago, for example:
<iframe loading="lazy" title="Should a prescription be required for purchasing pseudoephedrine?" width="500" height="281" src="https://www.youtube.com/embed/34TDQcVRqG4?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
So this is the first possibility for why they&#8217;re pulling these drugs. Maybe it&#8217;s part of a larger effort to shift these decongestants to a prescription model, so that more people are seeing doctors and pharmacists — and there’s more money being made by everyone involved.
That&#8217;s one theory. The other possibility is that the FDA&#8217;s fraud simply couldn&#8217;t go on any longer, because the evidence that they&#8217;re lying about these drugs&#8217; effectiveness was becoming too overwhelming. If that&#8217;s the case, it wouldn&#8217;t exactly be the first time something like that happened. It was just a couple years ago that the FDA unanimously <a href="https://www.npr.org/2021/06/11/1005567149/3-experts-have-resigned-from-an-fda-committee-over-alzheimers-drug-approval#:~:text=Three%20experts%20have%20now%20resigned,every%20member%20on%20the%20panel." target="_blank" rel="noopener">approved</a> an Alzheimer&#8217;s drug called Aduhelm that didn&#8217;t work. This is one of the most expensive drugs available on the market. It costs more than $50,000 per year, per customer.
But the approval process didn&#8217;t go as smoothly as the FDA and the drug maker, called BioGen, would have liked. Several of the FDA&#8217;s experts resigned in protest after the agency approved Aduhelm, even though there was no evidence it did anything to treat Alzheimer&#8217;s. Here&#8217;s one of the experts who quit:
<iframe loading="lazy" title="A new Alzheimer&#039;s drug brings hope, controversy" width="500" height="281" src="https://www.youtube.com/embed/VVM5a6D3l6U?start=297&#038;feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
As you just heard, the entire premise of the drug was that you can cure Alzheimer&#8217;s by removing so-called &#8220;sticky plaques&#8221; in the brain. But it later emerged the research supporting that theory, which appeared in Nature magazine, was <a href="https://www.nbcnews.com/science/science-news/alzheimers-theory-undermined-accusations-fabricated-research-rcna39843" target="_blank" rel="noopener">doctored</a>. On top of that, serious side effects of the drug emerged, including brain bleeding.
So why did the FDA approve the drug? It turns out the agency had a <a href="https://www.nbcnews.com/health/health-news/fda-broke-protocols-approving-biogen-alzheimers-drug-congressional-rep-rcna63662" target="_blank" rel="noopener">close relationship</a> with the drug company, BioGen, throughout the approval process. This relationship, Congress later determined, broke the FDA&#8217;s own rules. But it worked out for BioGen. 
We see this phenomenon again and again. The federal government tells us that a drug works, and that they know exactly how it works. By the time we find out they&#8217;re lying, the drug company has made a ton of money. We saw something similar happen with SSRIs. For decades, we were told that low serotonin levels were linked to depression. Therefore, SSRI&#8217;s would fix that problem by allowing more serotonin in the brain. Even as mass shootings and depression and suicide rates all went up, we were assured by Big Pharma and the media that SSRI&#8217;s were working. That was what the science said, and if you disputed it, you&#8217;re a troglodyte. It only emerged last year that, in fact, low serotonin isn&#8217;t <a href="https://www.tpr.org/bioscience-medicine/2022-12-28/research-concludes-low-serotonin-does-not-cause-depression-what-does-that-mean-for-ssris" target="_blank" rel="noopener">linked</a> to depression at all.
Somehow that wasn&#8217;t a major scandal. SSRIs — which stands for selective serotonin reuptake inhibitors — were never pulled from the shelves, even though the official position of the scientific community is that low serotonin doesn&#8217;t cause depression. There were no massive class-action lawsuits that bankrupted the companies that made billions of dollars from these SSRIs, just as BioGen hasn&#8217;t been held accountable for its worthless Alzehimer&#8217;s drug, and just as no one in the Sackler family went to prison for lying about the addictiveness of opioids.
For all those reasons, we can assume Big Pharma and the government will continue to lie to us. If they don&#8217;t face consequences, they have no reason to change what they&#8217;re doing. That&#8217;s why, at this moment, our political leaders are gearing up for a new round of COVID decrees. These decrees have already arrived in Canada, where public health officials are now calling for children as young as six-months-old to receive COVID shots.
There are no clinical trials or studies that demonstrate that it&#8217;s safe or necessary in any way to give COVID shots to six-month-old children. Not a single one. And, to be honest, even if they had conducted trials, there would be reason to doubt those, as well. We are now at the point where, whatever the class of drug we&#8217;re talking about — whether it&#8217;s Alzheimer&#8217;s treatments, COVID shots, SSRIs, even decongestants — you can assume you&#8217;re being lied to. If you consume drugs that Big Pharma and the federal government are pushing, you&#8217;re running the risk that ten or twenty years from now, you&#8217;ll learn what it&#8217;s actually doing, and what the actual side effects might be. Whatever you take, and whatever your kids take, you simply have to factor that doubt into the equation. You have to keep in mind that, if something bad happens down the line, you&#8217;ll be told it&#8217;s breaking news, and that no one could have seen it coming. Even though the people who made the drug, in fact, knew it was coming. 
Is this an ideal situation from a public health perspective? Of course not. But it&#8217;s the system we have. And if there&#8217;s any upside to the news this week, it&#8217;s that no one — not even people who are just shopping for a decongestant — can deny it anymore.
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Expensive pills

Big Pharma Once Again Makes Billions Off Of A Drug That Doesn’t Work

Big Pharma Once Again Makes Billions Off Of A Drug That Doesn't Work

Big Pharma

Federal Government

Matt Walsh

Propaganda

Readers Pass

A panel of appeals court judges has ruled that a <a href="https://www.dailywire.com/news/doctors-accuse-fda-of-unlawfully-blocking-their-ability-to-treat-covid-19-patients-with-ivermectin" target="_blank" rel="noopener">lawsuit from several doctors</a> challenging the <a href="https://www.dailywire.com/topic/fda" target="_blank" rel="noopener">Food and Drug Administration</a> over its messaging on ivermectin can move forward after a federal judge had blocked the suit. 
The doctors sued the Department of Health and Human Services and the FDA, claiming their medical practices were harmed due to the FDA telling people not to take ivermectin, which some doctors have said could be used as a possible COVID treatment. HHS Secretary Xavier Beccera and FDA Commissioner Robert Califf are also named in the suit. 
“FDA is not a physician. It has authority to inform, announce, and apprise — but not to endorse, denounce, or advise,” Judge Don Willett <a href="https://www.courthousenews.com/wp-content/uploads/2023/09/fifth-circuit-ivermectin-order.pdf" target="_blank" rel="noopener">wrote</a> for the U.S. Court of Appeals for the Fifth Circuit. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”
The ruling referenced an FDA post to X that instructed people not to take ivermectin because “you are not a horse.” The FDA has approved ivermectin to treat certain infections, but it has urged the public not to use it to treat COVID. 
“The messaging traveled widely across legacy and online media. Left unmentioned in most of that messaging: ivermectin also comes in a human version. And while the human version is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose,” the ruling said. 
According to the ruling, the doctors each prescribed ivermectin to treat COVID and said the FDA’s messaging interfered with their medical practice. The doctors allege that the FDA’s actions on ivermectin violate the Administrative Procedure Act (APA), which governs how administrative agencies operate. 
“As such, the Doctors can use the APA to assert their ultra vires claims against the Agencies and the Officials,&#8221; the ruling said. &#8220;Even tweet-sized doses of personalized medical advice are beyond the FDA’s statutory authority.&#8221;
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“This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” <a href="https://boydengray.com/boyden-gray-pllc-federal-appeals-court-decision-takes-major-step-toward-holding-fda-accountable-for-overstepping-authority-and-unlawfully-interfering-with-practice-of-medicine/" target="_blank" rel="noopener">said</a> Jared Kelson, counsel at Boyden Gray PLLC, the firm that represented the doctors. “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.”
Mary Talley Bowden, one of the doctors challenging the FDA, celebrated the ruling with a post to X.
“A small win, or at least a step forward, in a monumental battle to protect the doctor-patient relationship from government tyranny. ONWARD!” she <a href="https://twitter.com/mdbreathe/status/1697819048686559523?s=61&amp;t=AmzjiawkPU-YZpTc7gahMw" target="_blank" rel="noopener">wrote</a>. 
Bowden was <a href="https://apnews.com/article/coronavirus-pandemic-business-texas-media-health-e1f97db1cda6335aff1523ebaf389bf7" target="_blank" rel="noopener">suspended</a> from Houston Methodist Hospital after she vocally opposed vaccine mandates and advocated using ivermectin to treat COVID. The hospital said her statements and actions were “harmful to the community.”
“Dr. Mary Bowden, who recently joined the medical staff at Houston Methodist Hospital, is using her social media accounts to express her personal and political opinions about the COVID-19 vaccine and treatments,” the hospital said.

Food And Drug Administration Headquarters In Maryland

‘Not A Physician’: Federal Judges Say Doctors Can Continue Suit Against FDA Over Ivermectin

Courts

COVID-19

Department of Health and Human Services

Ivermectin

Politics

Xavier Becerra

<a href="https://www.dailywire.com/topic/fda">The Food and Drug Administration</a> on Thursday approved the first daily birth control pill that does not require a prescription.
The over-the-counter birth control pill is a progestin-only pill called Opill that is produced by French drugmaker HRA Pharma.
&#8220;Today&#8217;s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,&#8221; Dr. Patrizia Cavazzoni, director of the FDA&#8217;s Center for Drug Evaluation and Research, said Thursday in a statement.
&#8220;When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy,&#8221; Cavazzoni said.
Opill is expected to become available sometime early next year at convenience stores, grocery stores, and for sale online. Opill was <a href="https://www.statnews.com/pharmalot/2023/05/10/fda-panel-votes-in-favor-of-the-first-ever-over-the-counter-birth-control-pill/" target="_blank" rel="noopener">approved</a> decades ago by the FDA, but up until now patients needed a prescription to get it.
In May, an independent FDA advisory panel voted unanimously to dub the over-the-counter birth control drug safe for most people.
Opill uses only progestin, a synthetic hormone that mimics progesterone, but other birth control pills use both estrogen and progestin, which <a href="https://medlineplus.gov/druginfo/meds/a601050.html" target="_blank" rel="noopener">work</a> to stop ovulation. The progestin-only pill, sometimes called the &#8220;minipill,&#8221; does <a href="https://www.mayoclinic.org/tests-procedures/minipill/about/pac-20388306" target="_blank" rel="noopener">not always</a> stop ovulation.
About two thirds of adult American women under 50 use some kind of contraception, and a third of those women use birth control pills, <a class="zZyg UbGl iFzk qdXb WCDh DbOX tqUt " href="https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings/" data-testid="prism-linkbase">according</a> to a 2022 Kaiser Family Foundation survey.
However, over the last few years some women have spoken out about how they feel hormonal birth control damaged their health, particularly the kind that includes estrogen as well. Women have reported depression, anxiety, mood swings, and even <a href="https://theweek.com/articles/656761/how-birth-control-almost-ruined-life" target="_blank" rel="noopener">their hair</a> falling out as a result of hormonal birth control.
A 2016 Danish <a href="https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2552796" target="_blank" rel="noopener">study</a> found that hormonal birth control was associated with depression, especially among teenagers.
Some OB-GYNs have even <a href="https://www.zrtlab.com/blog/archive/obgyn-not-prescribing-the-birth-control-pill/" target="_blank" rel="noopener">said</a> they refuse to prescribe hormonal birth control because it comes with too many health risks.
However, some doctors say the progestin-only pill <a href="https://familydoctor.org/progestin-only-birth-control-pills/" target="_blank" rel="noopener">comes</a> with fewer risks, even though it still disrupts a woman&#8217;s natural hormone cycle with synthetic hormones.
The FDA advisers <a href="https://abcnews.go.com/Health/fda-approves-1st-birth-control-pill-prescription/story?id=101210924" target="_blank" rel="noopener">raised</a> concerns about people, especially young teenagers, being able to pick up their birth control pills as easily as if they were picking up ibuprofen. In the end though, the FDA advisory panel decided the benefits of avoiding unwanted pregnancies outweighed the risks.
In its announcement Thursday, the FDA said the most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, and bloating.
The FDA <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive">said</a> making the pill available without a prescription may help reduce the number of unintended pregnancies and their &#8220;potential negative impacts,&#8221; noting that the U.S. has 6.1 million unintended pregnancies per year.
&#8220;Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes,&#8221; the FDA said.
Opill should be taken at the same time every day to make sure it is effective, the FDA said.

US-HEALTH-JUSTICE-ABORTION-POLITICS

FDA Greenlights First Birth Control Pill With No Prescription

Abortion

Birth Control

Health Care

<a href="https://www.dailywire.com/topic/elon-musk" target="_blank" rel="noopener">Elon Musk&#8217;s</a> Neuralink neurotechnology startup company received approval from the U.S. Food and Drug Administration (FDA) on Thursday to launch its first in-human clinical study.
&#8220;This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,&#8221; the company said on <a href="https://twitter.com/neuralink/status/1661857379460468736" target="_blank" rel="noopener">Twitter</a>.
Musk has touted that over the years, the experimental brain-chip implant could treat neurological disorders such as paralysis and blindness by bridging signals between existing neurons, and would allow humans to save and replay memories, <a href="https://www.reuters.com/investigates/special-report/neuralink-musk-fda/" target="_blank" rel="noopener">saying</a> that &#8220;the future is going to be weird.”
Neuralink received FDA breakthrough designation for its technology three years ago, and Musk repeatedly claimed that human trials would begin immediately. However, the company had its application rejected in early 2022 by the FDA over safety concerns.
Seven current and former FDA employees <a href="https://www.reuters.com/investigates/special-report/neuralink-musk-fda/" target="_blank" rel="noopener">told</a> Reuters earlier this year that the agency&#8217;s major safety concerns involved &#8220;the device&#8217;s lithium battery; the potential for the implant&#8217;s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue.&#8221;
&#8220;We want to be extremely careful and certain that it will work well before putting a device into a human,&#8221; Musk said, according to Reuters. &#8220;The progress at first, particularly as it applies to humans, will seem perhaps agonizingly slow, but we are doing all of the things to bring it to scale in parallel. So, in theory, progress should be exponential.&#8221;
The approval comes as U.S. lawmakers requested that regulators <a href="https://www.reuters.com/world/us/us-lawmakers-seek-probe-how-elon-musks-brain-chip-venture-oversees-animal-2023-05-12/" target="_blank" rel="noopener">investigate</a> how the company has conducted animal testing and if those trials were rushed or resulted in failed experiments.
Neuralink has also faced other federal investigations, including from the USDA&#8217;s Inspector General over concerns of violating the Animal Welfare Act and the U.S. Department of Transportation over accusations over the movement of hazardous pathogens.
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Neuralink officials said the recruitment process for its clinical trial has not yet opened.
The FDA has not issued a statement about the approval.
Analysts from Grand View Research expect the worldwide market specific to brain implants to witness a compound annual growth rate above 9% over the next five years. The growing population of senior citizens, who are more likely to suffer from diseases such as Parkinson&#8217;s and Alzheimer&#8217;s, is expected to serve as a key market for the technology.
Deep brain stimulators, which send electrical impulses through electrodes implanted in the brain, currently occupy the largest market share in the broader brain implant space. Increased awareness of the treatment options for neurological movement disorders is expected to accelerate growth in the sector.
Vagus nerve stimulators, which send impulses to the brain through the vagus nerve, are expected to grow at the fastest annualized rate.
News of the advancements in brain-computer interface technology comes as firms rush to develop artificial intelligence solutions.
Paradromics, a <a class="editor-rtfLink" href="http://dailywire.com/topic/silicon-valley" target="_blank" rel="noopener">company</a> seeking to build direct data interfaces with the human <a class="editor-rtfLink" href="https://www.dailywire.com/topic/brain" target="_blank" rel="noopener">brain</a>, earned a breakthrough device designation last week from the FDA, granting the firm an expedited review process to incorporate the <a class="editor-rtfLink" href="http://dailywire.com/topic/technology" target="_blank" rel="noopener">technology</a> into <a class="editor-rtfLink" href="https://www.dailywire.com/topic/health-care" target="_blank" rel="noopener">medical</a> applications. The company is seeking to <a class="editor-rtfLink" href="https://www.paradromics.com/about" target="_blank" rel="noopener">develop</a> an implanted brain-computer interface, also called a BCI, that can function outside of a laboratory to assist patients who lose the physical ability to speak or type, such as those impacted by spinal cord injuries and strokes.
Earlier this month, researchers at the University of Texas in Austin unveiled a <a class="editor-rtfLink" href="https://www.dailywire.com/news/scientists-unveil-ai-that-can-turn-thoughts-into-written-text" target="_blank" rel="noopener">system</a> that uses AI to transform a person&#8217;s brain activity into written words. The &#8220;semantic decoder&#8221; learns how to translate thoughts as the person listens to podcasts, and the system concurrently measures brain activity, then produces text that mirrors the meaning of the individual&#8217;s thoughts. The system does not require implants but is impractical for use outside of a laboratory.
Ben Zeisloft contributed to this report.

Elon Musk’s Neuralink Startup Receives FDA Approval For First In-Human Brain Chip Implant Clinical Study

Paradromics, a <a href="http://dailywire.com/topic/silicon-valley" target="_blank" rel="noopener">company</a> seeking to build direct data interfaces with the human <a href="https://www.dailywire.com/topic/brain" target="_blank" rel="noopener">brain</a>, earned a breakthrough device designation from the <a href="https://www.dailywire.com/topic/fda" target="_blank" rel="noopener">Food and Drug Administration (FDA)</a>, which will grant the firm an expedited review process to incorporate the <a href="http://dailywire.com/topic/technology" target="_blank" rel="noopener">technology</a> into <a href="https://www.dailywire.com/topic/health-care" target="_blank" rel="noopener">medical</a> applications.
The company is seeking to <a href="https://www.paradromics.com/about" target="_blank" rel="noopener">develop</a> an implanted brain-computer interface, also called a BCI, that can function outside of a laboratory to assist patients who lose the physical ability to speak or type, such as those impacted by spinal cord injuries and strokes. The designation from the FDA occurs as Paradromics, which has received $47 million in venture funds and $18 million in federal funds to advance the technology, announces an additional $33 million funding round.
&#8220;This designation recognizes the transformative promise of our device, and we look forward to continued coordination with the FDA to accelerate its availability,” Paradromics CEO Matt Angle said in a <a href="https://www.prnewswire.com/news-releases/paradromics-raises-33-million-in-funding-achieves-breakthrough-medical-device-designation-from-fda-301827969.html?tc=eml_cleartime" target="_blank" rel="noopener">press release</a>. “And this investment validates our leadership position among the small group of BCI platform companies on the verge of commercialization.&#8221;
Paradromics will also seek to address motor and sensory deficits, chronic pain, and mood disorders, as well as treatment-resistant mental illnesses, which the company says represents a $240 billion market in the United States.
Other ventures have noted the various potential applications for brain implants: Neuralink, the brain-computer interface firm started by Elon Musk, also received FDA breakthrough designation for its technology three years ago. The company has repeatedly claimed that human trials would imminently start, although Neuralink has not yet received FDA authorization for the move, according to a recent investigative <a href="https://www.reuters.com/investigates/special-report/neuralink-musk-fda/" target="_blank" rel="noopener">report</a> from Reuters.
Neuralink posted a job <a href="https://www.dailywire.com/news/elon-musks-neuralink-makes-its-next-move-to-begin-human-trials-for-brain-implants" target="_blank" rel="noopener">advertisement</a> last year for individuals who would “work closely with some of the most innovative doctors” on the company’s first clinical trials, as well as help to “build the team responsible for enabling Neuralink’s clinical research activities and developing the regulatory interactions that come with a fast-paced and ever-evolving environment.”
The worldwide market specific to brain implants is expected to witness a compound annual growth rate above 9% over the next five years, according to an <a href="https://www.grandviewresearch.com/industry-analysis/brain-implants-market" target="_blank" rel="noopener">analysis</a> from Grand View Research. The growing population of senior citizens, who are more likely to suffer from diseases such as Parkinson’s and Alzheimer’s, is expected to serve as a key market for the technology.
Deep brain stimulators, which send electrical impulses through electrodes implanted in the brain, currently occupy the largest market share in the broader brain implant space. Increased awareness of the treatment options for neurological movement disorders is expected to accelerate growth in the segment. Vagus nerve stimulators, which send impulses to the brain through the vagus nerve, are expected to grow at the fastest annualized rate.
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News of the advancements in brain-computer interface technology comes as firms rush to develop artificial intelligence solutions. Researchers at the University of Texas in Austin unveiled a <a href="https://www.dailywire.com/news/scientists-unveil-ai-that-can-turn-thoughts-into-written-text" target="_blank" rel="noopener">system</a> earlier this month which uses AI to transform a person’s brain activity into written words. The “semantic decoder” learns how to translate thoughts as the person listens to podcasts and the system concurrently measures brain activity, then produces text that mirrors the meaning of the individual’s thoughts. The system does not require implants but is impractical for use outside of a laboratory.

Paradromics

Rival To Elon Musk’s Neuralink Moves Closer To FDA-Approved Brain Implant

Startup Moves Closer To FDA-Approved Brain Implant

Business

<a href="https://www.dailywire.com/show/candace" target="_blank" rel="noopener">Candace Owens</a> will question the narrative on childhood vaccinations in her new show “<a href="https://www.dailywire.com/show/a-shot-in-the-dark" target="_blank" rel="noopener">A Shot in the Dark</a>,” where she will discuss the medical establishment’s push to give children dozens of shots before they turn 18. 
In “A Shot in the Dark,” Owens takes a non-political approach and uses mainstream sources to inform parents about vaccine ingredients, schedules, and the listed potential side effects while asking basic questions that she says doctors often ignore. The show will be available on <a href="https://get.dailywire.com/subscribe/plus?utm_campaign=dailywire&amp;utm_medium=paid&amp;utm_source=googlesearch&amp;utm_content=na_subscriptions&amp;mid=g&amp;cid=dailywire&amp;xid=0&amp;gclid=CjwKCAjw3ueiBhBmEiwA4BhspK-KAKdVqiX1kGPv2GF22RDn3hLI-i_gVONg5pqLWdniRagJqgJoCBoC330QAvD_BwE" target="_blank" rel="noopener">DailyWire+</a>. The first three episodes will be free for everyone beginning on Thursday, and new episodes will release weekly, with the first three episodes also available on YouTube.     
“I am not going to try to convince you not to vaccinate your children,” Owens said. “That is not what I am being tasked with. It is not what is in my heart or soul to do. What I want to give you instead is information.”
Owens points out the conflicting claims regarding vaccine safety from the FDA and CDC, federal agencies that encourage parents to have vaccines administered to their newborns. In episode 1, Owens dives into the history of childhood vaccines, looking at how the number of vaccines and doses dramatically increased beginning in the mid-1980s after children first started receiving shots in the 1960s. She also questions the narrative that vaccines are making people healthier and shares her own traumatic story after receiving the Gardasil HPV vaccine. 
“The slur of calling somebody an anti-vaxxer has been tremendously effective throughout my lifetime, and I thought it was the crazy, crunchy people who wanted their children to die that didn&#8217;t vaccinate their children,” Owens said. “But … your life experiences transform you. And I had a life experience that transformed me in the form of me being vax injured.”
Episodes 2 and 3 focus on the Vitamin K shot, where Owens shows that it’s more than “just a vitamin,” and male infant circumcision, where she questions the idea that circumcising newborns is more sanitary.   
“I want to use CDC data,” she added. “I want to take a look at the FDA inserts when I talk about what can happen if you give your child a vaccine. These are things that the pediatrician does not supply you with, which should be astounding to you.”
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New episodes of “A Shot in the Dark” will release every Thursday, and will be available exclusively for <a href="https://get.dailywire.com/subscribe/plus?utm_campaign=dailywire&amp;utm_medium=paid&amp;utm_source=googlesearch&amp;utm_content=na_subscriptions&amp;mid=g&amp;cid=dailywire&amp;xid=0&amp;gclid=CjwKCAjw3ueiBhBmEiwA4BhspK-KAKdVqiX1kGPv2GF22RDn3hLI-i_gVONg5pqLWdniRagJqgJoCBoC330QAvD_BwE" target="_blank" rel="noopener">DailyWire+ members</a> after the third installment.

Candace Owens/A Shot in the Dark

Candace Examines Mainstream Narrative On Childhood Vaccines In New Show ‘A Shot In The Dark’

Candace Owens

Vaccines

This article is adapted from today’s Morning Wire Afternoon Update. To listen to the podcast version, click <a href="https://www.dailywire.com/podcasts/morning-wire" target="_blank" rel="noopener">here</a>.
GOP Reveals Damning Case Against Biden Family
In a <a href="https://www.dailywire.com/news/house-republicans-lay-out-damning-case-of-biden-familys-alleged-corruption" target="_blank" rel="noopener">press conference today</a>, Republican lawmakers laid out detailed evidence showing that at least nine members of President Joe Biden’s family took in millions of dollars from foreign sources. This allegedly began during the Obama administration while Biden was vice president. The lawmakers — who are all members of the House Oversight and Accountability Committee — revealed bank records showing payments as high as $10 million from foreign companies to Biden’s son, Hunter Biden. South Carolina Congresswoman Nancy Mace says the money was moved through a series of shell companies she believes were designed to cover the Biden family’s tracks.
“This could be the most corrupt scheme in American politics, where a sitting vice president … where we saw members of his family, nine of them so far, there may be more that were enriched from countries all over the world,&#8221; Mace said. 
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&quot;This could be the most corrupt scheme in American politics.&quot; <a href="https://t.co/fj5FNmRAWz">pic.twitter.com/fj5FNmRAWz</a>
&mdash; MAGA War Room (@MAGAIncWarRoom) <a href="https://twitter.com/MAGAIncWarRoom/status/1656291172644429825?ref_src=twsrc%5Etfw">May 10, 2023</a></blockquote>
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Committee Chairman James Comer (R-KY) released a memo prior to the news conference revealing that the Biden family allegedly set up more than 20 companies to take in foreign money, possibly in exchange for influencing policy.
&#8220;The Bidens have received millions of dollars from China,&#8221; Comer said. &#8220;It is inconceivable that the president did not know about it. The White House refuses to correct the president&#8217;s statements. Showing the president is now using the federal government to run interference for his families and his own role in these schemes.”
Border Chaos
 The first 550 of an <a href="https://www.dailywire.com/news/in-major-reversal-biden-resurrects-trump-border-policy-ahead-of-title-42-repeal" target="_blank" rel="noopener">expected</a> 1,500 active-duty U.S. troops arrived at the southern border on Tuesday. The Biden administration is beefing up border security ahead of an expected surge when Title 42 is repealed late Thursday. Today, the president gave a warning.
“It&#8217;s gonna be chaotic for a little while,&#8221; the president said.
Biden officials have put in place what they describe as a &#8220;comprehensive, multi-agency, multi-country plan&#8221; to &#8220;humanely manage the border.&#8221; 
That plan includes over 24,000 law enforcement personnel and 1,100 processing coordinators alongside the military reinforcements. And in a major reversal for Biden, it also includes putting in place Trump-era border policies that Biden once criticized, such as rejecting asylum applications from migrants who didn’t first request asylum in countries they traveled through, such as Mexico. 
For migrants who are processed, an administration memo reportedly directs Border Patrol agents to quickly release them into the U.S. without a court date or way to track them.
U.S. Army Sergeant Sentenced Over BLM Killing
A U.S. Army sergeant who was <a href="https://www.dailywire.com/news/army-sergeant-sentenced-for-death-of-black-lives-matter-protester" target="_blank" rel="noopener">convicted</a> in the shooting death of a Black Lives Matter protester was sentenced to 25 years in prison today. His lawyers argue it was self-defense. Thirty-five-year-old Daniel Perry shot and killed 28-year-old Garrett Foster at an Austin, Texas, BLM rally in 2020, in what he claims was self-defense. Prosecutors said Perry initiated the incident when he drove into a crowd gathered at the protest. Foster — who was carrying an AK-47 — then approached Perry’s car while motioning for him to roll his window down. Perry then shot Foster with a handgun. Perry told police that he believed Foster was going to aim the firearm at him. Texas Governor Greg Abbott has submitted a request to pardon Perry to the Texas Board of Pardons and Paroles.
Inflation Rises
The consumer price index <a href="https://www.dailywire.com/news/headline-inflation-ticks-downward-as-some-product-categories-continue-to-surge" target="_blank" rel="noopener">rose 4.9%</a> between April 2022 and April 2023, marking a slight decline from elevated <a href="http://dailywire.com/topic/inflation" target="_blank" rel="noopener">inflation</a> — even as higher price levels continue to constrain household budgets. Food prices were flat, but energy prices rose 0.6%, and housing prices, which are one of the largest contributors to the overall month-to-month increase, rose 0.4%.
Santos Arrested
Rep. George Santos (R-NY) has been federally <a href="https://www.dailywire.com/news/george-santos-arrested-indicted-on-13-counts-relating-to-fraud" target="_blank" rel="noopener">indicted</a> and was arrested today on 13 counts relating to campaign finance fraud and other charges, including false statements to Congress, theft of public funds, and wire fraud.
&#8220;It&#8217;s a witch hunt! It makes no sense. … You have Joe Biden&#8217;s entire family receiving deposits from … foreign destinations into their bank accounts … and yet no investigation is launched into them!&#8221; Santos said.
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SANTOS: &quot;It&#39;s a witch hunt! It makes no sense&#8230;You have Joe Biden&#39;s entire family receiving deposits from&#8230;foreign destinations into their banks accounts&#8230;and yet no investigation is launched into them!&quot; <a href="https://t.co/0oRixUtYlH">pic.twitter.com/0oRixUtYlH</a>
&mdash; Townhall.com (@townhallcom) <a href="https://twitter.com/townhallcom/status/1656376386955755520?ref_src=twsrc%5Etfw">May 10, 2023</a></blockquote>
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Over-The-Counter Birth Control Pill?
Today, an <a href="https://www.axios.com/2023/05/09/fda-advisers-birth-control-over-the-counter" target="_blank" rel="noopener">FDA advisory panel</a> unanimously approved making birth control pills available over the counter. The FDA still has to accept the recommendation, but the U.S. could be one step closer to birth control being available without a prescription.
Newsom Throws Cold Water On Reparations Bill
And, California Governor Gavin Newsom <a href="https://www.foxnews.com/politics/california-gov-newsom-declines-back-reparations-checks-says-slaverys-legacy-more-cash-payments" target="_blank" rel="noopener">declined</a> to endorse recent recommendations from a state reparations panel task force which would have sent as much as $1.2 million each to descendants of slaves in California. The Taskforce was created in 2020 in the wake of the George Floyd riots, and on Monday released a preliminary report advocating billions of dollars in wealth redistribution to make up for the sins of slavery.
 Newsom told Fox News that the group’s independent findings and recommendations are a “milestone” in the bipartisan effort to advance justice and promote healing. He also said that dealing with the legacy of slavery is about “much more than cash payments,” and noted that many of the recommendations put forward by the Task Force are critical action items already being addressed. Newsom pledged to advance what he called “systemic changes that ensure an inclusive and equitable future for all Californians.&#8221;
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To listen to the audio version of this podcast, <a href="https://podcasts.apple.com/us/podcast/morning-wire/id1576594336" target="_blank" rel="noopener">click here</a>. And for more in-depth discussion of the biggest stories of the day, listen to the latest full episode of Morning Wire every morning.
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George Santos, Joe Biden

Wednesday Afternoon Update: GOP Reveals Damning Case Against Biden Family, Santos Arrested, Border Chaos

Wednesday Afternoon Update: GOP Lays Out Biden Family Money Making Scheme, Santos Arrested, Border Chaos

Border

California

Gavin Newsom

General

George Santos

Hunter Biden

Morning Wire

Nearly 60 years after scientists tried and disastrously failed to develop a vaccine for respiratory syncytial virus (RSV), the Food and Drug Administration has approved the first-ever <a href="https://www.dailywire.com/news/pfizer-seeks-fda-approval-of-first-vaccine-to-protect-infants-by-injecting-pregnant-mothers-late-stage-trial-failed-to-meet-one-of-two-goals" target="_blank" rel="noopener">RSV shot</a>.
On Wednesday, the FDA gave a thumbs-up to Arexvy, the RSV vaccine developed by British pharmaceutical company GSK, which is intended for those 60 years old and up. The vaccine is a single shot and could be available for seniors as soon as the fall, CNN <a href="https://www.cnn.com/2023/05/03/health/first-rsv-vaccine-approved/index.html" target="_blank" rel="noopener">reported</a>.
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine" target="_blank" rel="noopener">said</a> Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
RSV attacks the lungs and breathing passages, and can cause pneumonia and bronchitis in older adults, according to the FDA. The Centers for Disease Control and Prevention estimates that up to 10,000 people aged 65 and older in the U.S. die after contracting RSV each year.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” Marks said.
RSV also poses a higher risk to infants with between 100-300 babies dying in the U.S. from the virus each year. Along with the new RSV shot for older adults, the FDA is also currently considering granting approval to a first-of-its-kind Pfizer vaccine that is administered to expectant mothers during the second half of their pregnancy to protect infants against RSV.
According to the late-stage <a href="https://www.dailywire.com/news/pfizer-seeks-fda-approval-of-first-vaccine-to-protect-infants-by-injecting-pregnant-mothers-late-stage-trial-failed-to-meet-one-of-two-goals" target="_blank" rel="noopener">trial data</a>, Pfizer’s experimental vaccine was 82% effective in preventing severe cases of the potentially deadly virus in infants 90 days after birth, but that dropped to 69% efficacy in preventing severe infections up to 180 days after a baby is born. The Pfizer shot also failed to meet its second goal of reducing non-severe illness in newborns, Reuters reported.
The FDA’s approval of the GSK vaccine comes after nearly six decades of attempts at developing a shot for RSV.
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The first try at producing an RSV vaccine in the late 1960s ended in disaster when two children died and many were hospitalized with severe RSV after taking the experimental vaccines, according to CNN. During the trial, 80% of the vaccinated children were hospitalized compared to only 5% who got the placebo. The tragedy forced researchers to put a pause on developing an RSV vaccine.
After eight years of study, researchers at Johns Hopkins University revealed <a href="https://www.reuters.com/article/us-rsv-shot/research-shows-why-1960s-rsv-shot-sickened-children-idUSTRE4BM4SH20081223" target="_blank" rel="noopener">findings</a> in 2008 that showed the late 1960s RSV vaccine trial failed because children’s antibodies were not binding to the inactivated virus strongly enough, Reuters reported. The antibodies, instead, were pulling the dead virus with them, causing the immune system to respond with a massive attack.
Now, scientists have high hopes for the rollout of RSV vaccines. An international study on the GSK vaccine looked at 25,000 people 65 and older and found that one dose of the vaccine was nearly 83% effective at preventing lung infections that stem from RSV, the Associated Press <a href="https://apnews.com/article/rsv-vaccine-respiratory-virus-60a8b859c692a593b652f68ff25738be" target="_blank" rel="noopener">reported</a>. The trial data also showed that the risk of severe infections was reduced by 94%.
Pfizer also has a vaccine for older adults similar to Arexvy that the FDA is currently considering approval for.

Respiratory Syncytial Virus

FDA Approves First-Ever RSV Vax Nearly 60 Years After Disastrous Experimental Shot

Disease

Health

World

President <a href="https://www.dailywire.com/topic/joe-biden" target="_blank" rel="noopener">Joe Biden</a> and Vice President <a href="https://www.dailywire.com/topic/kamala-harris" target="_blank" rel="noopener">Kamala Harris</a> responded to the Supreme Court&#8217;s ruling on mifepristone.
The White House released statements from both Biden and Harris Friday evening responding to the Supreme Court&#8217;s ruling allowing mifepristone for now. The Court ruled on Friday that the FDA&#8217;s approval of the abortifacient drug, used in nearly half of abortions nationwide, could remain in place while the Fifth Circuit Court of Appeals hears a lawsuit.
&#8220;Today, the Supreme Court granted the Department of Justice’s emergency stay application in Alliance for Hippocratic Medicine v. FDA, preventing a lower court decision from going into effect that would have undermined FDA’s medical judgment and put women’s health at risk,&#8221; Biden&#8217;s <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2023/04/21/statement-from-president-joe-biden-on-the-supreme-courts-decision-in-alliance-for-hippocratic-medicine-v-fda/" target="_blank" rel="noopener">statement</a> read. &#8220;As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts. I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.&#8221;
&#8220;The stakes could not be higher for women across America,&#8221; Biden added. &#8220;I will continue to fight politically-driven attacks on women’s health. But let’s be clear – the American people must continue to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v Wade.&#8221;
&#8220;We welcome the Supreme Court’s decision to grant a stay in Alliance for Hippocratic Medicine v. FDA, and our fight to defend reproductive freedom continues,&#8221; <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2023/04/21/statement-by-vice-president-kamala-harris-on-the-supreme-courts-decision-in-alliance-for-hippocratic-medicine-v-fda/" target="_blank" rel="noopener">Harris</a> added in her statement. &#8220;The Court’s announcement preserves access to mifepristone—a safe and effective medication that was approved by the FDA more than two decades ago.&#8221;
&#8220;Our Administration will not waver in our commitment to preserving access to essential medication and defending the FDA’s ability to approve safe and effective drugs,&#8221; she continued. &#8220;Americans need to look no further than their medicine cabinet to see how many FDA-approved medications are at risk if lower court decisions disregarding the FDA’s scientific judgment are allowed to stand. The President and I will continue to fight to protect a woman’s freedom to make decisions about her own body and access to reproductive health care, including medication abortion. No one should stand between a woman and her doctor.&#8221;
On Friday, the nation’s highest court <a href="https://www.dailywire.com/news/supreme-court-releases-decision-on-abortion-pill-mifepristone" target="_blank" rel="noopener">blocked</a> a ruling from a federal judge in Texas that placed restrictions on the FDA’s approval of the drug. The Supreme Court ruled to allow the approval of the drug while a lawsuit proceeds in federal court, granting requests from the Biden administration and the manufacturer.
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“The applications for stays presented to JUSTICE ALITO and by him referred to the Court are granted,” the Court wrote in its <a href="https://s3.documentcloud.org/documents/23785998/22a901-22a902-order.pdf" target="_blank" rel="noopener">decision</a>. “The April 7, 2023 order of the United States District Court for the Northern District of Texas, case No. 2:22–cv–223, is stayed pending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari, if such a writ is timely sought. Should certiorari be denied, this stay shall terminate automatically. In the event certiorari is granted, the stay shall terminate upon the sending down of the judgment of this Court.”

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Biden, Harris Respond To Supreme Court Keeping Abortion Drug Mifepristone In Place

White House Responds To Supreme Court Keeping Abortion Drug Mifepristone In Place

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The Supreme Court issued a ruling on the abortion drug <a href="https://www.dailywire.com/topic/abortion" target="_blank" rel="noopener">mifepristone</a>.
The nation&#8217;s highest court blocked a ruling from a federal judge in Texas that placed restrictions on the FDA&#8217;s approval of the drug, which is used in about half of all abortions. The Supreme Court ruled to allow the approval of the drug while a lawsuit proceeds in federal court, granting requests from the Biden administration and the manufacturer.
&#8220;The applications for stays presented to JUSTICE ALITO and by him referred to the Court are granted,&#8221; the Court wrote in its <a href="https://s3.documentcloud.org/documents/23785998/22a901-22a902-order.pdf">decision</a>. &#8220;The April 7, 2023 order of the United States District Court for the Northern District of Texas, case No. 2:22–cv–223, is stayed pending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari, if such a writ is timely sought. Should certiorari be denied, this stay shall terminate automatically. In the event certiorari is granted, the stay shall terminate upon the sending down of the judgment of this Court.&#8221;
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Supreme Court Releases Decision On Abortion Pill Mifepristone

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The FDA approved a the use of a drug combination that represents the first approved therapy in roughly 20 years for patients newly-diagnosed with diffuse large B-cell lymphoma, the non-Hodgkins lymphoma most prevalent in the U.S.
The drug Polivy in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) was <a href="https://finance.yahoo.com/news/fda-approves-roches-polivy-combo-155324627.html" target="_blank" rel="noopener">approved on Wednesday</a>, The combination had been approved in 2019 for use but only for patients who had undergone two prior therapies.
“It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma,” <a href="https://www.curetoday.com/view/fda-approves-polivy-regimen-for-dlbcl" target="_blank" rel="noopener">said</a> Dr. Levi Garraway, chief medical officer and head of global product development for Genentech, which manufactures Polivy. “Today’s decision from the FDA to approve Polivy in combination with R-CHP in this setting brings a much-needed new treatment option which may improve outcomes and bring other benefits to many patients with this aggressive lymphoma.”
A study found that roughly 28 months after the combination was administered, a 27% reduction in the risk of disease production or death for patients occurred compared to patients who received standard of care.
“The FDA’s decision gives newly diagnosed patients with this aggressive form of lymphoma their first new treatment option in nearly two decades,” Lee Greenberger, Ph.D., Chief Scientific Officer of The Leukemia &amp; Lymphoma Society, <a href="https://www.lls.org/news/fda-approves-treatment-patients-newly-diagnosed-most-common-lymphoma?utm_source=Twitter&amp;utm_medium=Social&amp;utm_campaign=04-20-2023-LLS-FDA-Approval-DLBCL-ZGM" target="_blank" rel="noopener">stated</a>. “One of our major goals at LLS is to support science that moves us toward less toxic, and more effective treatment options, and this drug combination is a step in that direction.”
“While this new drug is a valuable addition for some patients, we need to keep pressing forward to find even better options for DLBCL and every type of blood cancer,” Greenberger added. “But advances like polatuzumab are important, not just for today’s patients, but because science builds on itself, helping us to learn more about effective use of target drugs and harnessing the immune system to help tomorrow’s patients do even better.”
“I believe this gain in progression-free survival is clinically meaningful for patients, and also leads to a reduction in the need for subsequent therapy,” Grzegorz Nowakowski, MD, of the Mayo Clinic Comprehensive Cancer Center in Rochester, Minnesota, said.

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FDA Approves Treatment For Newly-Diagnosed Lymphoma That’s 1st Approved Therapy In Decades

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