And offering a fast-track to approve drugs the Trump administration views as a priority. Welcome to the new Food and Drug ...

In 2023 Dr. Vinay Prasad said that scientists who recognized the limitations of randomized-controlled trials (RCTS) were ...

The Food and Drug Administration announced the launch of a new program to fast-track agency approvals for drug manufacturers ...

The FDA plans to “rapidly make available” rare disease drugs and make use of surrogate endpoints to get promising medicines ...

FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s ...

Sarepta Therapeutics (NASDAQ:SRPT) reported a second fatality from acute liver failure in a patient treated with its gene ...

The U.S. Food and Drug Administration has tapped Dr. Vinay Prasad, an oncologist who has previously criticized FDA leadership and COVID-19 mandates, as the director of its Center for Biologics ...

Sarepta Therapeutics Inc. plummeted after reporting a second patient died of acute liver failure while being treated with its gene therapy for a rare muscle disorder.The death of the 15-year-old boy ...

If there’s anything that Dr. Vinay Prasad, the controversial new appointee to lead the Center for Biologics Evaluation and Research, or CBER, a top office at the Food and Drug Administration ...

In the past two weeks, U.S. public health authorities have skirted normal procedures and announced two major policy changes ...