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 ...

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...

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

Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, ...

Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...

The U.S. FDA said on Monday that it recommends lifting the voluntary hold on Sarepta Therapuetics' gene therapy, Elevidys, in ...

The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...

Sarepta led investors to believe that its ELEVIDYS therapy was both safe and had potential for approval in wider applications. The Company misled the market about its revenue outlook on ELEVIDYS.

NEW YORK – The US Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's gene therapy for treating Sanfilippo syndrome type A (MPS IIIA). Novato, California-based Ultragenyx ...

– Company reports sequential quarterly growth of 32.8% over Q1 2025 with a record 13,434 YCANTH ® dispensed applicator units in Q2 2025 – – Company reports receipt of $8 million milestone payment from ...