News

FDA’s Prasad Exits Following Political Backlash Over Sarepta
Vinay Prasad, a top regulator at the US Food and Drug Administration, left the agency after a short-lived tenure that ended ...
Sarepta finally gets some good news: A patient death wasn’t its DMD drug’s fault.
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
STAT5d
FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
FDA Says Sarepta Can Resume Gene Therapy in Some Patients
In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...
FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
Fierce Pharma1d
Untangling Sarepta’s gene therapy fallout and a growing trust deficit
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
Sarepta Stock Rises Despite Downgrade and FDA Probe. The Crisis Explained.
Sarepta shares gained even though the U.S. Food and Drug Administration said late Friday that it was probing the death of an ...