The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

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

The Trump FDA tries to kill a therapy that has helped boys with a deadly diagnosis.

Shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) plunged 10% after the company disclosed that the U.S. Food and Drug ...

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 ...

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...

Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

Shipments of Elevidys for nonambulatory DMD patients remain suspended while the Company evaluates an enhanced immunosuppressive regimen for these patients.

Sarepta Therapeutics has rejected a call by the Food and Drug Administration to stop shipments of its muscular dystrophy drug ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

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