Evidence-based medicine "Boy Wonder" Dr. Vinay Prasad was fired as CBER Director after less than three months on the job.

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

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 ...

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.

PTC Therapeutics faces pivotal FDA decisions for approvals that could potentially transform their long-term revenues. Click ...

The U.S. Food and Drug Administration's (FDA) top vaccine official is stepping down after just three months in a role that ...

Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) is a biotechnology company specializing in RNA interference (RNAi) therapeutics ...

Alnylam Pharma raised its revenue outlook as its heart drug sees quick uptake.