Just how many employees is Sarepta Therapeutics laying off? And why did the FDA reject Ultragenyx's rare disease drug over ...

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—a market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

Approval may be around the corner for Sarepta Therapeutics’ Duchenne muscular dystrophy drug Eteplirsen since its biggest critic, Ronald Farkas, MD, PhD, left his role at the Food and Drug ...

Sarepta Therapeutics saw its stock drop by 26% on 6 May after the US Food and Drug Administration (FDA) announced that Vinay Prasad will lead its Center for Biologics Evaluation and Research (CBER ...

Japan-based NS Pharma filed for FDA approval Oct. 2 for its Duchenne muscular dystrophy treatment, dealing another blow to Sarepta, whose Duchenne drug was rejected by the FDA in August.

Sarepta noted that the FDA had proactively asked if the company has considered using additional immunosuppression, ... A full market withdrawal is not out of the question, though.

Shares of Sarepta Therapeutics closed down as much as 42% to hit a nine-year low of $18.30 on Monday after a second death of a male teenage patient who had received its gene therapy, Elevidys ...

FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...