FDA seems poised to approve a new drug for ALS, but does it work?
In March, experts who advise the FDA questioned the efficacy of an experimental new drug for ALS. In September, they voted to approve it anyway.
Food and Drug Administration
FDA shortens the wait time between Moderna vaccine and booster to 5 months
Now, both the Pfizer and the Moderna booster shots can be given five months after the second dose of vaccine — down from six months.
Moderna's COVID-19 Vaccine Becomes 2nd To Earn FDA Authorization
The Food and Drug Administration greenlights the biotech firm's vaccine for emergency use in the U.S. The move bolsters a vast inoculation effort that's already underway.
Some Vials Of COVID-19 Vaccine Contain Extra Doses, Expanding Supply
"Given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial," the FDA said Wednesday.
FDA Authorizes COVID-19 Vaccine For Emergency Use In U.S.
Pfizer and BioNTech's vaccine is the first to receive an emergency authorization from the Food and Drug Administration. Officials say it may be ready for widespread inoculations within days.
FDA Adviser: Vaccine To Be OK'd In Days, But 'Normal' May Not Return Until Next Fall
The Food and Drug Administration's authorization of a COVID-19 vaccine could come in a day or two, a member of an FDA expert panel says. But he says it may be late 2021 before normalcy returns.
Pfizer Asks FDA To Approve Its COVID-19 Vaccine For Emergency Use
The pharmaceutical giant and partner BioNTech announced Friday that they are submitting a formal request to the Food and Drug Administration, just days after the vaccine was shown to be 95% effective.
Federal Trade Commission Cracks Down On Unproven COVID-19 Treatment
The Federal Trade Commission issued warning letters to several companies that marketed an unproven drug to treat COVID-19. Sales of the nonapproved drug, thymosin alpha-1, were first reported by NPR.
FDA's Hahn Apologizes For Overselling Plasma's Benefits As A COVID-19 Treatment
The Food and Drug Administration's chief said Sunday the therapy reduces deaths among COVID-19 patients by 35%. On Monday he apologized, acknowledging that statistic greatly exaggerates any benefit.
Top Health Officials Enter Self-Quarantine After Exposure To Coronavirus
Three members of the White House coronavirus task force — FDA Commissioner Stephen Hahn, CDC Director Robert Redfield and Director Anthony Fauci — are isolating themselves for two weeks.