Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...

Donald Trump reportedly ignored calls from Health Secretary Robert F. Kennedy Jr. not to fire the top vaccine official at the Food and Drug Administration after a pressure campaign from far-right ...

The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.

A controversial hematologist-oncologist who joined FDA this spring and quickly became its top regulator has left the ...

In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and ...

Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.

Sarepta (NASDAQ:SRPT) stock, Replimune (NASDAQ:REPL) stock and Capricor (CAPR) stock surge as FDA's biologics head exits abruptly. Read more here.

Vinay Prasad, M.D., has left the FDA less than three months into the role as director of the Center for Biologics Evaluation ...

After turning down several new drugs and restricting use of another, Dr. Vinay Prasad drew the ire of the right-wing ...

A spokesperson for the Health Department has said that Vinay Prasad did not want to be a "distraction to the great work of the FDA in the Trump administration." ...

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...

The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, ...