In his resignation letter, Dr. Aaron Kesselheim calls it "probably the worst drug approval decision in recent U.S. history." An FDA official says the agency found the benefits outweighed the risks.
The FDA has authorized storing the Pfizer-BioNTech COVID-19 vaccine at refrigerator temperatures for up to a month. Previously the vaccine could only be kept in a regular fridge for up to 5 days.
Ages 12 and older are now eligible to be vaccinated against COVID-19, the FDA and the CDC say. But when and where, and what about younger kids? You have questions. We have answers.
The Food and Drug Administration gave Johnson & Johnson's vaccine the green light for emergency use Saturday, a day after a panel of advisers to the agency endorsed it in a unanimous vote.
The Food and Drug Administration released an analysis of Johnson & Johnson's COVID-19 vaccine Wednesday morning that appears to support its authorization for emergency use.
Tattoo artists are unhappy about a new ban on blue and green pigments in Europe, while scientists say the basic science of tattoo ink is still fairly mysterious.
The Food and Drug Administration is working on a playbook for how it could greenlight vaccine tweaks. Studies in hundreds of people, rather than tens of thousands, seem likely.
The case was the first abortion-related decision faced by the new conservative majority of the U.S. Supreme Court after Justice Amy Coney Barrett was sworn in last year.
Agency officials said reducing the number of doses creates a potential for harm in patients because "they may assume that they are fully protected when they are not" and may "take unnecessary risks."
Advisers to the Food and Drug Administration voted 20-0 to recommend that the agency authorize Moderna's vaccine for emergency use during the pandemic. There was a single abstention.
Despite being founded a decade ago, Moderna has never had a product make it to market. And the company registered its first factory with the Food and Drug Administration just this week.
The Food and Drug Administration says is advising health workers to use "every full dose obtainable" to help speed up the nationwide immunization campaign.
Two days before a panel of experts is set to review Moderna's COVID-19 vaccine and advise the Food and Drug Administration, documents show the vaccine is 94% effective and well-tolerated.
States are starting to administer their first doses of Pfizer's newly FDA-authorized COVID-19 vaccine. It marks a new phase in the pandemic, but what's that mean for you?
