Sources also say that the administration plans to split CBER in two, with one of the section focused entirely on vaccines.

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 ...

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

Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...

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, 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." ...

Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office ...