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

Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), ...

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

The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, ...

A controversial hematologist-oncologist who joined FDA this spring and quickly became its top regulator has left the ...

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

Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...

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

The Food and Drug Administration’s top vaccine and gene therapy official resigned on Tuesday after a public campaign against ...

In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...

The SPDR® S&P Biotech ETF rebounded over 20% since lows in April, despite changes at the FDA that could have signaled a ...