Tag Archives: FDA

FDA Approves Pfizer Booster For Kids Ages 12-15

CNBC reports: The Food and Drug Administration on Monday expanded eligibility for Pfizer and BioNTech booster shots to children ages 12 to 15 years old, as school restarts after winter break amid a surge of Covid infections across the U.S. The FDA also shortened the time between primary vaccination and the booster dose to at least five months, down from …

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FDA Approves At-Home Test For All Known Variants

NBC News reports: Tens of millions. That’s how many rapid COVID-19 tests Indianapolis-based Roche Diagnostics plans to make, now that they have the green light from the Food and Drug Administration. The FDA granted emergency use authorization Friday for an at-home COVID-19 test developed by Roche. The test is for individuals ages 2 and older and can be collected and …

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FDA Authorizes Merck’s COVID Treatment Pill

CNBC reports: The Food and Drug Administration authorized on Thursday Merck’s antiviral pill to treat Covid-19 for emergency use, adding another tool to the nation’s arsenal to combat the virus. The FDA’s move comes a day after it authorized for another antiviral drug, from Pfizer. Merck’s treatment, known as molnupiravir and developed in partnership with Ridgeback Biotherapeutics, is cleared for …

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BREAKING: FDA Approves Pfizer’s COVID Treatment Pill

The Associated Press reports: U.S. health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus. The drug, Paxlovid, is a faster, cheaper way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously …

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FDA Approves First Injectable Drug For HIV Prevention

Via press release from the FDA: Today, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude is given first as two initiation injections administered one month apart, and then every …

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FDA Likely To Approve COVID Treatment Pills This Week

Bloomberg News reports: The U.S. Food and Drug Administration is poised to authorize a pair of pills from Pfizer Inc. and Merck & Co. to treat Covid-19 as soon as this week, according to people familiar with the matter — a milestone in the fight against the pandemic that will soon expand therapies for the ill. An announcement may come …

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FDA Permanently Lifts Restriction On Abortion Pills

The New York Times reports: The federal government on Thursday permanently lifted a major restriction on access to abortion pills. It will allow patients to receive the medication by mail instead of requiring them to obtain the pills in person from specially certified health providers. The decision, by the Food and Drug Administration, comes as the Supreme Court is considering …

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FDA Panel Approves Merck’s COVID Treatment Pill

NBC News reports: A Food and Drug Administration advisory panel voted Tuesday to recommend Merck’s experimental antiviral pill to treat Covid-19 for emergency use authorization, paving the way for the agency to clear the first oral drug for the disease. Members of the agency’s Antimicrobial Drugs Advisory Committee voted 13-10 in favor of the treatment, called molnupiravir, for use in …

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House Panel Seeks Interview With Trump’s FDA Head

The Hill reports: The House subcommittee investigating the U.S. response to the coronavirus wants to question Stephen Hahn, former President Trump’s Food and Drug Administration commissioner, about attempts to improperly interfere with the agency’s review of COVID-19 therapeutics and vaccines. The committee on Monday sent a letter to Hahn asking him to sit for an interview on Dec. 16, and …

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Boosters Open To All Adults After Final CDC Approval

The Associated Press reports: The U.S. on Friday opened COVID-19 booster shots to all adults and took the extra step of urging people 50 and older to seek one, aiming to ward off a winter surge as coronavirus cases rise even before millions of Americans travel for the holidays. Under the new rules, anyone 18 or older can choose either …

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FDA Approves Pfizer, Moderna Boosters For All Adults

The Washington Post reports: Federal regulators on Friday authorized Pfizer-BioNTech and Moderna coronavirus vaccine boosters for all adults, a one-size-fits-all strategy designed to shore up Americans’ defenses against a tenacious virus and reduce confusion over guidelines that have varied based on people’s age, occupation and where they live. The Food and Drug Administration cleared the boosters for people 18 and …

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CDC Advisors Recommend Pfizer Vaccine For Kids 5-11

NPR reports: Children ages 5 through 11 years may soon be able to get a low-dose COVID-19 vaccine made by Pfizer-BioNTech. Advisors to the Centers for Disease Control and Prevention voted unanimously to recommend the shots Tuesday for the approximately 28 million children in this age group. If the recommendations are endorsed by CDC director Dr. Rochelle Walensky, as expected, …

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FDA Approves Low Dose Pfizer Vax For Kids 5-11

CNBC reports: The Food and Drug Administration on Friday authorized the use of Pfizer and BioNTech’s Covid-19 vaccine for children ages 5 to 11, a move that will make the shots available to 28 million kids in the U.S. The Centers for Disease Control and Prevention must sign off before shots can be distributed. It’s scheduled an advisory committee meeting …

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FDA Panel Okays Pfizer Vax For Children Ages 5-11

The New York Times reports: A key advisory committee to the Food and Drug Administration voted overwhelmingly to recommend the use of Pfizer-BioNTech’s coronavirus vaccine in 5- to 11-year-olds, bringing the vaccine a big step closer to about 28 million children. Shots could be offered as early as next week. The panel endorsed giving the age group one-third of the …

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FDA Approves Moderna And J&J Vaccine Boosters

CNBC reports: The Food and Drug Administration Wednesday night authorized booster shots of both Johnson & Johnson and Moderna’s Covid vaccines, another critical step in distributing extra doses to tens of millions of people. At the same time, U.S. regulators also authorized “mixing and matching” vaccines, allowing Americans to get a booster shot that’s a different vaccine from the one …

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FDA To Allow Over-The-Counter Sales Of Hearing Aids

Via press release from the FDA: Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category …

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Erickson Falls For Fake Pro-Masturbation “FDA” Flyer

Mediaite reports: On Monday night, conservative pundit Erick Erickson tweeted out a flyer purporting to be part of The Real Cost, an anti-tobacco campaign developed by the U.S. Food and Drug Administration. The top of flyer reads, “Pleasure yourself with Nicotine? Try masturbation instead!” The flyer further says, “Masturbation is a safe and healthy alternative to vaping as a solution …

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FDA To Allow “Mix And Match” For Booster Shots

The New York Times reports: The Food and Drug Administration is planning to allow Americans to receive a different Covid-19 vaccine as a booster than the one they initially received, a move that could reduce the appeal of the Johnson & Johnson vaccine and provide flexibility to doctors and other vaccinators. The government would not recommend one shot over another, …

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FDA Panel Approves Johnson & Johnson Vax Booster

CNBC reports: An influential Food and Drug Administration advisory committee on Friday said the agency should authorize boosters of Johnson & Johnson’s single-shot Covid-19 vaccine to the more than 15 million Americans who have already received the initial dose. The unanimous vote – by the agency’s Vaccines and Related Biological Products Advisory Committee – is a critical step before the …

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FDA Advisory Panel Recommends Moderna Booster

The New York Times reports: A key advisory committee to the Food and Drug Administration voted on Thursday to recommend a booster shot of the Moderna coronavirus vaccine for many of the vaccine’s recipients, at least six months after a second dose. The panel endorsed a half-dose as a third injection for people 65 and older as well as younger …

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