Jefferies analysts said these detailed safety outcomes confirm the gene therapy's positive risk/benefit profile in ambulatory ...

Sarepta Therapeutics is selling off Arrowhead Pharmaceuticals’ shares to stretch its cash runway, while also inking a share ...

CBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out ...

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

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.

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

BACK TO CBER — Dr. Vinay Prasad has returned to the FDA’s Center for Biologics Evaluation and Research, leaving industry and ...

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

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

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

FDA head wanted Vinay Prasad back at the Center for Biologics Evaluation and Research, and some pharma firms are taking a hit ...

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