FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

The Food and Drug Administration said Friday it will add a new warning and other limitations to a gene therapy for Duchenne’s muscular dystrophy that's been linked to two patient deaths. The infused therapy from Sarepta Therapeutics will carry a boxed warning — the most serious type — alerting doctors and patients to the risk of potentially fatal liver failure with the treatment, the FDA said in a release. The one-time therapy, Elevidys, has been under FDA scrutiny since the company reported t