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

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

Sarepta reported a quarter-on-quarter dip in sales for its Duchenne gene therapy. Elsewhere, Jazz won FDA approval of a brain ...

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 ...

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

SRPT rallies after Q2 earnings and revenue beat expectations as Elevidys deliveries resume following FDA clearance.

Dr. Vinay Prasad is back at the FDA less than two weeks after the White House pressed the head of the agency to remove him ...

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

At the U.S. Food and Drug Administration's (FDA) request, Vinay Prasad is returning to the role of director of the Center for ...

The FDA is allowing Sarepta to resume shipments of Elevidys (delandistrogene moxeparvovec) to ambulatory patients with Duchenne muscular dystrophy.

Vinay Prasad, a top vaccine regulator ousted from the Food and Drug Administration (FDA) late last month, is set to return to ...