FDA
Pfizer asked the Food and Drug Administration on Tuesday to authorize emergency use of the experimental pill, which has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections.
The company’s filing comes as new infections are rising once again, driven mainly by hot spots in states where colder weather is driving more Americans indoors.
Hearing aids may soon be available over the counter. Last week the FDA issued a proposal to allow hearing aids to be sold directly to consumers, without a medical exam or fitting by an audiologist.
Moderna hasn't yet gotten the nod to offer its vaccine to teens but is studying lower doses in younger children while it waits. Researchers tested two shots for the 6- to 11-year-olds, given a month apart, that each contained half the dose given to adults.
Millions more Americans can get a COVID-19 booster and choose a different company’s vaccine for that next shot, federal health officials said Thursday.
More than 650 people have been infected with salmonella oranienburg nationwide, including 37 people in Illinois, according to federal health officials.
Within hours of formal approval, which is expected after the Food and Drug Administration signs off and a Centers for Disease Control and Prevention advisory panel meets on Nov. 2-3, millions of doses will begin going out to providers across the country, along with the smaller needles needed for injecting young children.
But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel later this week before finalizing official recommendations for who should get boosters and when.
Federal regulators are expected to authorize the mixing and matching of COVID-19 booster shots this week in an effort to provide flexibility for those seeking to maintain protection against the coronavirus.
U.S. health advisers endorsed a booster of Johnson & Johnson’s COVID-19 vaccine Friday, citing growing worry that Americans who got the single-dose shot aren’t as protected as those given two-dose brands.
The panel of outside advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, as well as younger adults with other health problems, jobs or living situations that put them at increased risk from COVID-19.
The Food and Drug Administration said Thursday it will ask its outside experts to meet in late November to scrutinize Merck’s pill to treat COVID-19.
The Food and Drug Administration is wrestling with whether and when to offer another dose of the single-shot Johnson & Johnson COVID-19 vaccine, while a new study out Wednesday raises the prospect that using a different brand as the booster might work better.
With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it's their turn.
If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill shown to treat COVID-19. All other FDA-backed treatments against the disease require an IV or injection.
Drugmaker Merck said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus, potentially a leap forward in the global fight against the pandemic.