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The Food and Drug Administration (FDA) announced Friday it has approved the first flu vaccine that can be self-administered, with this version being a nasal spray as opposed to an injection. The vaccine FluMist, manufactured by MedImmune, which was acquired by AstraZeneca in 2007, was first approved by the FDA in 2003 for individuals between five and 49 years of age. Its approval has since been expanded to include children as young as two years old. With the FDA’s announcement Friday, FluMist is officially the first flu vaccine that can be administered without a healthcare provider’s involvement. The spray contains...

The FDA has just written a letter to pharma-giant AbbVie, asking the company to cease running an advertisement for a migraine drug that features tennis legend Serena Williams. The letter details that the advertisement for Ubrelvy 'makes false or misleading representations' about the drug, and might lead migraine patients to believe that, 'all patients who take Ubrelvy can expect their migraine pain to be eliminated after a single dose of Ubrelvy, when this has not been demonstrated'. It asks the company to come up with a plan to cease running the advertisement or discontinue distribution of the drug. AbbVie reported...

Cows in California have tested positive for highly pathogenic avian influenza (HPAI) and are now in quarantine, according to the state's Department of Food and Agriculture (CDFA). California hosts a fifth of the nation's dairy cows, and it is the number one producer of milk, butter, and ice cream, and the number two producer of cheese and yogurt in the US. The current infections of HPAI among cattle in the US started in March, when a 'mysterious' illness broke out among dairy cows in Texas...These cows were the first in the world to officially test positive for the bird flu...

The U.S. Food and Drug Administration (FDA) has authorized a new COVID-19 vaccine from Novavax, giving Americans an alternative to shots from Moderna and Pfizer.Novavax’s protein-based vaccine will be available soon after regulators granted emergency authorization to the Maryland-based company for the product. FDA officials said that animal testing data supported the decision.“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said in an Aug. 30 statement.The FDA cleared vaccines from...

“The mainstream media hasn’t caught up with the science, but the science is out there now and it’s devastating.” “Yesterday, the chief attorney for FDA admitted, because he lost a case in court against a doctor, that there was no reason to discourage people from taking Ivermectin. Ivermectin was a very devastating cure for Covid. It literally obliterated Covid. By depriving people of Ivermectin, millions of people around the globe died. There were cures for Covid from day one … but they didn’t want that, they wanted the vaccine only. There’s a little-known federal rule that they were all aware...

CNN — The US Food and Drug Administration is poised to sign off as soon as this week on updated Covid-19 vaccines targeting more recently circulating strains of the virus, according to two sources familiar with the matter, as the country experiences its largest summer wave in two years. The agency is expected to greenlight updated mRNA vaccines from Moderna and Pfizer/BioNTech that target a strain of the virus called KP.2, said the sources, who declined to be named because the timing information isn’t public. It was unclear whether the agency simultaneously would authorize Novavax’s updated shot, which targets the...

The Centers for Disease Control and Prevention will spend $5 million to vaccinate livestock workers against the seasonal flu in an effort to prevent possible interaction with bird flu, officials said today, July 30. If someone gets both the H5N1 (highly pathogenic avian influenza) and seasonal flu, the result could be “an exchange of genetic material” that could do what scientists call “reassortment” and the development of a new influenza virus, said Nirav Shah, the principal deputy director at CDC. Shah spoke to reporters in a call organized by the Health and Human Services Department. The $5 million will go...

Attorney Tom Renz has issued a stark warning about the FDA's decision to grant Emergency Use Authorization (EUA) to bird flu mRNA vaccines. Looking ahead, he says, “So what I would expect now is when Disease X rolls out, when the bird flu is something that they're gonna claim has made some sort of a dent in the human population, they're gonna try and push the bird flu vaccines in the same way that they pushed the COVID vaccines.” Renz cited a study showing gain-of-function research on bird flu in the United States before painting a chilling picture of the...

The US Food and Drug Administration has approved a blood test to be used for colorectal cancer screening among average-risk adults 45 and older. The maker of the test, Palo Alto, California-based biotechnology company Guardant Health, announced Monday that this is the first blood test to be approved by the FDA as a primary screening option for colorectal cancer, and it’s the first approved blood screening test for colorectal cancer that meets requirements for Medicare reimbursement. For patients with commercial insurance plans, the cost of the test may vary depending on their individual plan coverage. The list price for the...

Dr. Robert Redfield, the former director of Centers for Disease Control and Prevention (CDC) said Thursday that the U.S. Food and Drug Administration (FDA) pushed a false “safe and effective” COVID vaccine narrative by underreporting adverse events. The mRNA shots “never should have been mandated,” Redfield told the Senate Committee on Homeland Security and Governmental Affairs Committee on Thursday. The Democrat-controlled Senate oversight hearing entitled “Risky Research: Oversight of U.S. Taxpayer Funded High-Risk Virus Research,” included witnesses Dr. Gerald Parker, Dr. Carrie Wolinetz, Dr. Kevin Esvelt, and Redfield. Former President Trump’s CDC director accused the Biden government of suppressing data...

Are ectopic pregnancies increasing? A notable increase in the number of women seeking emergency care for ectopic pregnancies is causing obstetricians and emergency room physicians to take notice. A recent large-scale study of nearly one million pregnancies over a decade found “significant increase” in ectopic pregnancies. The study confirmed ectopic pregnancy remains one of the leading causes of maternal mortality in the United States. In addition to highest trends for younger women, the incidence was particularly higher for mothers over 40 years in age and non-Hispanic Black women. * 2006–2010: The rate of ectopic pregnancy diagnoses per 1,000 pregnancies increased...

Katherine Watt has been corresponding with a reader who is researching the history of US public health and regulatory agencies. Records before 1973 are difficult to locate. However, what has become clear is that the origins of these agencies are not what they make them out to be.Why are they lying about their origins? Because, Watt says, “they have maintained a bunch of empty office buildings that serve only as mailing addresses … There are no technicians in the buildings, there’s no equipment and no sample testing occurs.”Katherine Watt is a mom, Catholic, and paralegal from Pennsylvania, USA. On her...

Washington — In a blockbuster decision Friday, the Supreme Court overruled a 40-year-old decision that directed federal courts to defer to agencies' interpretation of unclear laws enacted by Congress. The landmark ruling from the court, which divided 6-3 along ideological lines, curtails the regulatory power of federal agencies and is expected to restrict the government's ability to impose regulations on areas like the environment, health care and the workplace. The decision marks a major victory for the conservative legal movement, which has long called for dismantling the framework that arose out of the 1984 ruling in a case known...

On Thursday, three Democratic senators introduced a bill to legalize the distribution of the abortion pill by mail. The abortion pill has become America’s most popular form of abortion, due to its lower cost and liability to the abortion industry. Yet a federal law known as the Comstock Act prevents the abortion industry from mailing the pills to women, outlawing the shipping of “every article or thing designed, adapted or intended for producing abortion” via the U.S. mail. Senators Tina Smith (D-Minn.), Elizabeth Warren (D-Mass.), and Catherine Cortez Masto (D-Nev.) introduced a bill to repeal the abortion provision of that...

For a third time, Sarepta Therapeutics has convinced a top Food and Drug Administration official to overrule the prevailing view of their staff and approve a drug for Duchenne muscular dystrophy. On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year. That decision, documents concurrently released by the agency show, was made almost exclusively by Peter Marks, the agency’s director of the Center for Biologics Evaluation and Research. He...

Gynuity Health Projects, a research organization conducting clinical trials aimed at expanding access to the abortion pill and overturning the Food and Drug Administration’s safety requirements, is funded by organizations with deep historic ties to the American eugenics movement. Gynuity’s donor list includes organizations like the Bill and Melinda Gates Foundation, Planned Parenthood, the Population Council, the John D. and Catherine T. MacArthur Foundation, the Society for Family Planning, the Rockefeller Foundation, the Tara Health Foundation, the William and Flora Hewlett Foundation, the David and Lucile Packard Foundation. In 1996, the Packard Foundation seeded the pill’s manufacturer, Danco Laboratories, Inc.,...

Yesterday, the Supreme Court unanimously dismissed a case filed against the Food and Drug Administration for wrongfully expanding access to mifepristone, the first of two drugs utilized for medical abortions. The lawsuit was brought by the Alliance Defending Freedom on behalf of a group of medical professionals known as the Alliance for Hippocratic Medicine. When originally approved by the FDA in 2000, mifepristone could only be prescribed by a licensed physician after an in-person appointment and required an in-person follow-up to ensure that the abortion had been completed “safely.” In 2016, the Obama administration expanded the list of who could...

The Supreme Court on Thursday rejected a challenge to the abortion pill mifepristone, meaning the commonly used drug can remain widely available. The court found unanimously that the group of anti-abortion doctors who questioned the Food and Drug Administration’s decisions making it easier to access the pill did not have legal standing to sue.

<p>SCOTUS’s imminent immunity decision (it will not be narrow, not after the clown show in Manhattan) will blow the Alvin Bragg case to smithereens. The NDA was not a crime. The NDA payment by Trump’s legal counsel is alleged to have been an attempt to influence the 2016 election and only became an alleged “crime” by the method chosen for reimbursement to said lawyer.</p>

On XMay 21, 2024