The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

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

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

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...

Vinay Prasad, the U.S. Food and Drug Administration's chief medical and science officer, has left the health regulator, the U ...

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

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

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

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...

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