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.

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

(Reuters) -Sarepta Therapeutics shares surged more than 30% before the bell on Tuesday, as analysts said the resumption of ...

In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the ...

It has been a tumultuous two weeks for Sarepta; however, the FDA reauthorising US shipments of Elevidys will be a welcome development.

Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment ...

The FDA concluded that a recent patient death in Brazil was unrelated to Sarepta’s Elevidys treatment, allowing the company ...

Sarepta Therapeutics said it will resume shipments of its gene therapy Elevidys® (delandistrogene moxeparvovec-rokl) “imminently” to ambulant patients with Duchenne muscular dystrophy (DMD), ending a ...

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

Researchers have discovered a new way to successfully collect amniotic fluid and stem cells directly during vaginal deliveries. Plus, Rush University System for Health is offering an innovative blood ...