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

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 ...

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 Department of Health and Human Services confirmed that Dr. Vinay Prasad, who led the FDA’s Center for ...

Analysts say the departure of the CBER head may alleviate overhang in the cell and gene therapy space. Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and ...

Vinay Prasad, appointed as FDA's top vaccine official, faced criticism and backlash during his short tenure. Controversies surrounded gene therapy safety and regulatory decisions affecting futures of ...

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

The Food and Drug Administration’s polarizing vaccine chief is leaving the agency after a brief tenure that drew the ire of ...

The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as Director of the Center for Biologics Evaluation and Research, a government ...

The abrupt exit of the former CBER director, who quickly made his mark at the agency with several high-profile and ...

Replimune (NASDAQ:REPL) stock surges as Cantor Fitzgerald upgrades, citing improved odds for approval of its lead drug after an FDA leadership change. Read more here.