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

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

Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...

A fter just a few controversial months, Vinay Prasad, MD, MPH, has stepped down as director of FDA's Center for Biologics Evaluation and Research (CBER).

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...

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

F.D.A. resignation: The Food and Drug Administration’s top vaccine and gene therapy official resigned on Tuesday after a ...

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has earned a $100 million milestone payment from ...

The Trump FDA tries to kill a therapy that has helped boys with a deadly diagnosis.

The FDA is investigating the death last month of an eight-year-old boy in Brazil who had received Sarepta Therapeutics’ Elevidys® (delandistrogene moxeparvovec-rokl)—though the company and its ...

The Revell family hoped a gene therapy could buy time for their sons, who have a rare and fatal disease. After two patients ...

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...