Moderna submitted data from 344 volunteers who got a third shot of the vaccine six months after their first two doses. The additional shot significantly boosted immunity, the company said.
Using the COVID vaccine "off-label" — whether that's for booster shots or young children — may be tempting to some vaccine providers, but the CDC warns it could get them into trouble.
The FDA announced the Pfizer vaccine is the first in the U.S. that is now fully approved. Here's what that means for vaccine mandates and convincing vaccine-hesitant people to get vaccinated.
More than 130 dogs died, 220 were sickened, and Midwestern Pet Food had inadequate food safety practices, the agency says. The company has recalled several products.
The FDA has expanded a nationwide recall of shrimp products from Avanti Frozen Foods sold at major retailers. So far, nine people in four states have contracted salmonella; three were hospitalized.
The FDA amended its emergency use authorizations for the Pfizer and Moderna vaccines to allow for an additional dose for some immunocompromised people.
In a U.S. House subcommittee meeting Wednesday, Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, agreed that “any flavor of e-cigarette left on the market is likely to encourage youth to start vaping” and that “if FDA banned all flavored e-cigarettes, less kids would continue to vape.”
The FDA is in the process of determining which, if any, e-cigarette manufacturers will be permitted to stay on the market.
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.