Tag Archives: FDA

Via press release from the FDA: Today, the U.S. Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use. The impacted products originated from the company’s distribution facility in …

NBC News reports: Pfizer-BioNTech is postponing its rolling application to the Food and Drug Administration to expand the use of its two-dose Covid-19 vaccine for children ages 6 months to 4 years. The move means that vaccines for this age group will not be available in the coming weeks, a setback for parents eager to vaccinate their young children. Pfizer …

The Washington Post reports: Coronavirus vaccines for children younger than 5 could be available far sooner than expected — perhaps by the end of February — under a plan that would lead to the potential authorization of a two-shot regimen in the coming weeks, people briefed on the situation said Monday. The FDA urged the companies to submit the application …

The Washington Post reports: The Food and Drug Administration has granted full approval to Moderna’s coronavirus vaccine, the agency announced Monday. Moderna’s vaccine, now known as Spikevax, was previously available under emergency use authorization and is the second coronavirus vaccine to get full FDA approval. Pfizer and BioNTech’s product was approved in August. Moderna, a biotechnology company, said Monday that …

CNN reports: The FDA could decide in the coming days to take steps to curb the use of antibody treatments produced by Eli Lilly and Regeneron, the source said, pointing to the growing body of evidence that shows their monoclonal therapies don’t effectively neutralize the virus’ Omicron variant. The NIH had recently updated its guidelines to advise clinics against using …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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, …

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 …

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 …

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 …