George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a ...

A spokesperson for the Department of Health and Human Services confirmed that Dr. Vinay Prasad, who led the FDA’s Center for ...

In this week’s edition of InnovationRx, we look at Halle Berry’s menopause startup, Ambience Healthcare’s $243 million ...

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

The MAHA-aligned Food and Drug Administration official responsible for overseeing vaccine and gene therapy approvals has been ...

After just a few controversial months, Vinay Prasad, MD, MPH, has stepped down as director of FDA's Center for Biologics ...

Vinay Prasad, a top regulator at the US Food and Drug Administration, left the agency after a short-lived tenure that ended ...

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

We recently published 11 Stocks That Jim Cramer Recently Talked About. Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is one of the ...

Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.

The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used ...

The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.