Officials at the U.S. Food and Drug Administration reported that at least 10 children died after receiving the COVID-19 ...

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...

In a closed meeting, Vinay Prasad pushes back on criticism of his vaccine policy changes, morale issues at the FDA, and his ...

FDA commissioners lambasted the CBER head’s plans to use a probe into COVID vaccine safety to upend longstanding regulatory ...

The commissioners’ concerns are in response to sweeping vaccine regulation changes earmarked by CBER head Vinay Prasad.

U.S. Food and Drug Administration officials said COVID-19 vaccines killed at least 10 children, providing no evidence for the ...

Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from ...

A confidential FDA memo is creating controversy after an official said the COVID-19 vaccine may have played a role in the deaths of at least 10 children.

The U.S. Food and Drug Administration has approved Axogen's nerve repair graft, the health regulator said on Wednesday, ...

The regulator is still investigating “additional adverse event cases," a spokesperson told Endpoints News on Wednesday.

While health secretary Robert F. Kennedy Jr. and others have pushed for more widespread use of CGMs as a wellness tool, the devices have long been critical survival tools for people with diabetes. The ...

The former officials said the FDA's plans to revamp how certain life-saving vaccines are handled would "disadvantage the ...