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 ...

Sarepta Therapeutics (SRPT) stock in focus as report says company hired a Trump-linked lobbying firm after deaths linked to ...

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

FDA reinstates Vinay Prasad to lead CBER as gene therapy safety concerns spotlight regulatory challenges in biotech manufacturing.

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

Sarepta shares dropped as much as 5.2 per cent on Monday amid volatile trading, while those of Replimune — another gene ...

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

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

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

After a strong launch for its cancer gene therapy, Ferring Pharmaceuticals is setting the stage for long-term growth.

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