STAT News reports that it came after a number of controversial decisions by the food and drug administration regarding a gene ...

Dr. Vinay Prasad, who came under fire from patient advocacy groups and Laura Loomer, is gone after less than three months on the job.

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

After our editorial, the agency relents to allow a Duchenne treatment.

Shares of Sarepta Therapeutics Inc. (SRPT) traded 20% higher on Tuesday afternoon after the U.S. Food and Drug Administration ...

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

Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...

Shipments of Elevidys for nonambulatory DMD patients remain suspended while the Company evaluates an enhanced immunosuppressive regimen for these patients.

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...