The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must ...

A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...

New FDA framework on changes coronavirus vaccine approval will be released “in the coming days,” FDA Commissioner Marty ...

The GOP-led House Judiciary Committee is requesting records from Pfizer’s CEO and an interview with a former company ...

With new testing requirements, it’s not even clear how new Covid or flu shots can be made available this fall.

A change in recommending Covid vaccines for children and pregnant women would circumvent an expert panel but please many MAHA ...

Dr. Vinay Prasad, the FDA's new vaccine chief, has been accused of spreading misinformation about Covid vaccines.

WASHINGTON (Reuters) -U.S. lawmakers on Thursday asked Pfizer Inc for information on alleged comments by a former executive ...

Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S.

"You could replace Peter Marks with a bobblehead doll that just stamps approval and you would have the same outcome at FDA ...

The independent experts will meet on May 22 to discuss updates to the COVID-19 vaccine for the upcoming season.

The Food and Drug Administration says that a prominent medical contrarian and critic of the drug industry will head its ...