Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.

Vinay Prasad, M.D., has left the FDA less than three months into the role as director of the Center for Biologics Evaluation ...

A spokesperson for the Department of Health and Human Services confirmed that Dr. Vinay Prasad, who led the FDA’s Center for ...

The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...

Vinay Prasad, appointed as FDA's top vaccine official, faced criticism and backlash during his short tenure. Controversies surrounded gene therapy safety and regulatory decisions affecting futures of ...

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...

Reeling from the deaths of two patients who took Duchenne muscular dystrophy gene therapy Elevidys, Sarepta is launching a ...

Sarepta Therapeutics Inc (NASDAQ:SRPT) shares are soaring in Wednesday’s after-hours session after the company announced a ...

After our editorial, the agency relents to allow a Duchenne treatment.

Sarepta Therapeutics is set to cut 500 jobs as part of its restructuring and pipeline prioritisation plan, which is expected to result in annual cash cost savings of $120m in 2026. With its pipeline ...