Michael Rogers had worked for the FDA for more than three decades, culminating in a role as the agency's associate commissioner for inspections and investigations. Colleagues said they were ...

The risk level is the FDA's second most severe level as it could cause "temporary or medically reversible adverse health consequences." The bottles contain the "presence" of nitrosamine drug ...

The Ixchiq vaccination, developed by Valneva to prevent the mosquito-borne chikungunya virus, was approved by the Food and Drug Administration (FDA) in November 2023 as the first of its kind.

I can't comment on any particular application. As you know, we have a bunch of applications for those booster shots," FDA Commissioner Dr. Marty Makary told CBS News chief Washington correspondent ...

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...

The FDA made the announcement in statement about "an aggressive timeline to scale use of artificial intelligence internally across all FDA centers by June 30, 2025, following the completion of a ...

Now it’s begging them to come back. Senior FDA officials asked laid-off employees in recent days to temporarily return after mass cuts decimated the agency’s ability to penalize retailers that ...

The terms need to be negotiated before Novavax’s vaccine could be granted full approval, the source said, declining to be named because they weren’t authorized to speak on behalf of the FDA.

The FDA said Tuesday that the review -- part of its "Operation Stork Speed" initiative -- will look at whether current nutrient requirements need to be updated, including whether additional ...