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

Sarepta plummets after a third death in its muscular dystrophy program for investigational gene therapies, prompts FDA action and intensifies safety scrutiny.

Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical ...

The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death ...

The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne muscular dystrophy who were treated with Sarepta Therapeutics’ gene therapy ...

FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety and regulatory concerns.

Earlier on June 4, Sarepta Therapeutics announced that the US FDA has granted Platform Technology Designation to the rAAVrh74 viral vector.

Sarepta’s stock dropped by 26% after the FDA named a vocal critic of its gene therapy programme to lead its biologics division.

Sarepta said more than 800 patients have received Elevidys so far, The Associated Press reported. Sarepta has secured FDA accelerated approval for three other Duchenne drugs since 2016.