BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the ...

After years of bashing the medical establishment, Drs. Vinay Prasad and Marty Makary are stuck in a trap. Any attempt to ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...

We want to know more about what these products are doing,” said Dr. Vinay Prasad in a recent FDA livestreamed presentation. The statement is made as there has been a significant policy shift in the U.

Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical ...

The FDA has a new director for the Center for Drug Evaluation and Research (CDER), with biopharma industry executive George ...

A series of recent changes could have significant implications for how Americans receive and pay for their shots.

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

Sarepta Therapeutics was approached for comment by Clinical Trials Arena but did not respond before publication. This comes ...

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

In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The ...