With a strong launch underway for a bladder cancer gene therapy, Ferring Pharmaceuticals is finding the kind of commercial ...

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

Some oncologists and researchers have raised concerns about delays in the completion of confirmatory trials, but FDA now has new tools to push them ahead.

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

Shares of several biotech firms fell in premarket trading Monday after reports that ousted U.S. Food and Drug Administration vaccine regulator Vinay Prasad will return to the agency.

In the wake of multiple patient deaths from liver injuries related to Sarepta Therapeutics’ AAV gene therapy platform, some ...

Sarepta Therapeutics said Friday that the deaths of two patients taking its marketed gene therapy Elevidys® (delandistrogene ...

Dr. Vinay Prasad’s rehiring was an unusual instance of a federal official targeted by the right-wing activist Laura Loomer ...

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

"At the FDA's request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research," U.S.

Sarepta Therapeutics Inc.’s shares soared after the US biotech reported revenue that beat estimates, which analysts ...

Sarepta did not hold an investor call for its second-quarter earnings report or provide an updated full-year revenue outlook.