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

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

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 ...

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

The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and ...

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

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

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

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

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

After our editorial, the agency relents to allow a Duchenne treatment.

Shares of Sarepta Therapeutics Inc. (SRPT) traded 20% higher on Tuesday afternoon after the U.S. Food and Drug Administration ...