By Zachary Stieber Contributing Writer Sarepta Therapeutics will not agree to a regulatory request to pause shipments of a ...

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for ...

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty ...

Sarepta stock has tanked. Most investors don’t see the drugmaker’s executive management as credible following the failure to disclose a patient death, a BMO survey suggests.

The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with ...

The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

The third death occurred in an adult male with limb girdle muscular dystrophy who received a Sarepta AAVrh74 gene therapy product, SRP-9004, in a phase 4 clinical trial.

As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we ...

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