The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation ...

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.

At the 2025 Alzheimer’s Association International Conference, one of the bigger splashes was made by an experimental cardiovascular drug. Newamsterdam Pharma Co. NV presented data showing that its ...

Susan Monarez, Ph.D., was confirmed by the Senate Tuesday as director of the Centers for Disease Control and Prevention (CDC) ...

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, a top FDA official, suddenly departed after a series of controversial decisions about a Duchenne gene therapy ...

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

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." ...