A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand. | A brief skirmish between ...

The U.S. Food and Drug Administration on Friday asked Sarepta to voluntarily halt shipments of the gene therapy, but the company refused to do so and said it would continue making the treatment ...

Sarepta Therapeutics reversed course and agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular ...

World markets are mixed after U.S. stock indexes hit new records. Oil prices fell and U.S. futures were little changed. Japan ...

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

Sarepta's pause on its prescription gene therapy drug for Duchenne muscular dystrophy gives the company time to work with the FDA on reviews. Infusions nationwide will be canceled. Also in the news, ...