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 ...

Dr Vinay Prasad has resigned from the FDA after less than three months amid controversy over Sarepta Therapeutics' gene ...

Biotech investors seemed to be taking the sudden departure of a top Food and Drug Administration official late Tuesday as a ...

Vinay Prasad resigns from the FDA after backlash over vaccine restrictions and gene therapy decisions. Political pressure cited in sudden departure.

Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.

The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...

Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), ...

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

Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...

Freshly appointed Center for Drug Evaluation and Research (CDER) leader George Tidmarsh M.D., Ph.D., will now take on the role of acting director of CBER as well, according to an internal letter from ...

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