The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

The FDA is expected to decide on treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis.

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

Regeneron Pharmaceuticals has received accelerated FDA approval for Lynozyfic, a new bispecific antibody treatment for adults with relapsed or refractory multiple myeloma who have undergone at least ...