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

Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...

The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.

Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.

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

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and ...

Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office ...

Hansa Biosciences’ Idefirix (imlifidase) has reduced patients’ antibodies to a level that allows dosing in patients with Duchenne muscular dystrophy (DMD) with Sarepta and Roche’s Elevidys ...

Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), ...

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy raised questions about a key FDA official who broke with Trump on regulation.

The former official, Vinay Prasad, had been on the job three months and had recently come under attack by conservative ...