Tag Archives: FDA

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 …

The Washington Post reports: The Food and Drug Administration authorized a set of e-cigarette products for sale in the United States for the first time on Tuesday after it concluded that the benefit to adult cigarette smokers outweighed the risk posed to young people. The authorization of an e-cigarette device and two accompanying nicotine cartridge products, which are sold under …

The New York Times reports: The federal government is expected to take a significant step this week toward offering booster doses to a much wider range of Americans as advisers to the Food and Drug Administration meet on Thursday and Friday to discuss recipients of the Johnson & Johnson and Moderna coronavirus vaccines. On Thursday, the F.D.A.’s advisory panel of …

NBC News reports: Pfizer-BioNTech requested Tuesday that the Food and Drug Administration clear its Covid-19 vaccine for use in children ages 5 to 11. The FDA is expected to take at least several weeks to analyze data collected in a trial that included more than 2,000 children before it would grant emergency use authorization. While the Pfizer vaccine has been …

CNN reports: Vaccine advisers to the US Centers for Disease Control and Prevention endorsed giving booster doses of Pfizer’s Covid-19 vaccine to people 65 and older long-term care facility residents, and certain people with underlying conditions. The CDC’s Advisory Committee on Immunization Practices voted unanimously on the question: “A single Pfizer/BioNtech covid 19 vaccine booster is recommended for persons aged …

The New York Times reports: After weeks of internal strife at the Food and Drug Administration, the agency on Wednesday authorized people over 65 who had received Pfizer-BioNTech’s coronavirus vaccine to get a booster shot at least six months after their second injection. The F.D.A. also authorized booster shots for adult Pfizer-BioNTech recipients who are at high risk of becoming …

The Washington Post reports: In an all-day FDA advisory meeting, experts resoundingly voted down Pfizer’s application for boosters for everyone 16 and older and is now debating whether to authorize an additional dose for older adults. The panelists may choose to green-light boosters for adults in older age brackets and with serious medical conditions that heighten their vulnerability to severe …

The Washington Post reports: A highly-anticipated Food and Drug Administration review of evidence on whether a booster shot of the Pfizer-BioNTech coronavirus vaccine is widely necessary struck a noncommittal tone Wednesday, setting the stage for a potentially fractious debate among expert advisers to the agency this week. Pfizer and government officials have relied heavily on data from Israel in making …

The New York Times reports: The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, making it the first to move beyond emergency use status in the United States. The decision will set off a cascade of vaccine requirements by hospitals, colleges, corporations and other organizations. United Airlines recently announced that …

The Daily Beast reports: You know it’s bad when the Food and Drug Administration has to take to Twitter on a Saturday to encourage people not to take the “horse paste” drug ivermectin to fight COVID-19. “You are not a horse. You are not a cow,” the agency tweeted, not bothering to dance around the facts. “Seriously, y’all. Stop it.” …

The New York Times reports: The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning. Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the …

NBC News reports: Federal health officials and medical experts are expected to recommend that most people in the U.S. who are eligible for Covid-19 vaccinations should get booster shots eight months after their second doses, according to two sources familiar with the discussions. The guidance, which would apply only to the two-shot Pfizer and Moderna regimens, could go into effect …

USA Today reports: The less than 3% of Americans who are severely immuno-compromised should be able to get an extra dose of the Pfizer or Moderna COVID-19 vaccine, the federal government decided Thursday night. People who are on medications or have diseases that suppress their immune system may not have gotten adequate protection from their earlier doses of COVID-19 vaccine …

Reuters reports: The United States Food and Drug Administration (FDA) is aiming to give full approval for the Pfizer Covid-19 vaccine by early September, the New York Times reported on Tuesday (Aug 3), citing people involved in the effort. The FDA gave emergency use authorization to the Pfizer vaccine late last year. Full approval by the FDA could push more …

CNN reports: Pfizer and BioNTech said Friday that the US Food and Drug Administration has granted priority review designation to their application for full approval of their Covid-19 vaccine, and an FDA official said the decision will come “soon”. The FDA official told CNN on Friday that a decision on full approval is likely to come within two months. The …

The Washington Post reports: The Food and Drug Administration on Thursday limited the recommended use of a controversial new Alzheimer’s drug to patients with mild cognitive impairment or early dementia from the disease — a major change from the original label that included everyone with the illness. The revised label clarifies that the drug, called Aduhelm, is intended for patients …

The New York Times reports: The U.S. government spent more than $18 billion last year funding drugmakers to make a Covid vaccine, an effort that lead to at least five highly effective shots in record time. Now it’s pouring more than $3 billion on a neglected area of research: developing pills to fight the virus early in the course of …

CNBC reports: The Food and Drug Administration on Monday approved Biogen Alzheimer’s drug aducanumab, making it the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades. The FDA’s decision was highly anticipated. The drug, which is marketed under the name Aduhelm, is …

CNBC reports: The Food and Drug Administration approved Pfizer and BioNTech’s request to allow their Covid-19 vaccine to be given to kids ages 12 to 15 on an emergency use basis, allowing states to get middle school students vaccinated before the fall. The U.S. agency granting use of the shot in adolescents will also accelerate the nation’s efforts to drive …

CNBC reports: Pfizer and partner BioNTech said they have started the process of seeking full approval for their Covid vaccine for use in people 16 and older in the U.S., making the companies the first in the nation to file for full regulatory approval. The Food and Drug Administration granted emergency authorization of their Covid vaccine in late December. Since …