Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...

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

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

Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would ...

Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...

Dr Vinay Prasad has resigned from the FDA after less than three months amid controversy over Sarepta Therapeutics' gene ...

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

Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, ...

The FDA has lifted its hold on Elevidys for ambulatory patients, after asking Sarepta to pause the treatment following three ...

In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the ...