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

The U.S. Food and Drug Administration (FDA) has recommended lifting the voluntary clinical hold on Elevidys for ambulatory patients with Duchenne Muscular Dystrophy (DMD), following a thorough ...

Vinay Prasad, a professor who until earlier this year headed a cancer-drugs and health-policy lab at UC San Francisco, ...

Vinay Prasad's interim replacement has concerns about same drug that drove him out. NIH director says employee critics ...

Sources also say that the administration plans to split CBER in two, with one of the section focused entirely on vaccines.

In a striking bipartisan move, the Senate Appropriations Committee voted 26-3 to boost the NIH’s budget by $400 million — rejecting the Trump administration’s proposed $17 billion cut and sweeping ...

Dr George Tidmarsh, a former pharmaceutical executive who joined the FDA this month, will take over Prasad’s role temporarily.

The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation ...

Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...

Allogene Therapeutics has reported a patient death tied to its anti-CD52 monoclonal antibody used for lymphodepletion in its ...

Two major health agencies are facing leadership reshuffles, with the resignations of the FDA’s Vinay Prasad and NICE’s Dr Sam Roberts.

Dr. Vinay Prasad, the chief scientific officer at the Food and Drug Administration, has resigned after only three months in the position.