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 ...

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 ...

Vinay Prasad is returning to his role overseeing vaccine, gene therapy and blood product regulation at the U.S. Food and Drug ...

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

Less than weeks after stepping down, Prasad will return to lead CBER “at the FDA’s request,” according to an HHS spokesperson ...

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.

After a second Elevidys patient death from acute liver failure, Sarepta in July launched a major restructuring that involves ...