Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...

A Food and Drug Administration official who stepped down less than two weeks ago is getting his job back as the agency’s top ...

Vinay Prasad, M.D., has rejoined the FDA, the latest turn in a monthslong stretch of leadership turnover at the agency. | “At ...

Dr. Vinay Prasad had been serving as the FDA's director of the Center for Biologics Evaluation and Research since May, and ...

The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new ...

Vinay Prasad returns as FDA's CBER director after brief exit, raising questions on rare disease drug approvals and mRNA ...

Vinay Prasad is once again head of the FDA’s Center for Biologics Evaluation and Research, after Laura Loomer led a campaign ...

The word from the FDA is that Prasad has come back at the request of the regulator's Commissioner, Marty Makary, who ...

WASHINGTON — Vinay Prasad is returning to the Food and Drug Administration to resume his role overseeing vaccine, gene ...

US Food and Drug Administration Commissioner Marty Makary said he’s trying to persuade Vinay Prasad, the agency’s former head of gene therapy and vaccines, to return to the FDA after his abrupt ...

One analyst speculated that, going forward, Prasad may be less “heavy-handed” in reviewing rare disease therapies given the ...

Dr. Vinay Prasad, the controversial critic of the US Food and Drug Administration who took a top role at the regulatory ...