The FDA had asked Sarepta to voluntarily halt all shipments of Elevidys following the deaths of three nonambulatory Duchenne ...

Shares of Sarepta surged Tuesday, a day after the FDA said the company could lift a voluntary pause on shipments of its Elevidys drug, which had been linked to three patient deaths this year. The ...

The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used ...

Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug Administration that it could resume shipping a drug it paused sales of last week.

Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.

Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...

The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

Sarepta Therapeutics ( NASDAQ: SRPT) was upgraded to Neutral from Underweight at J.P. Morgan as it sees FDA's Elevidys hold removal recommendation in ambulatory patients as a clear win.

Sarepta Therapeutics shares jumped over 36% on Tuesday after the company said it had received FDA approval to restart ...