In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...

Second death linked to Sarepta Therapeutics treatment leaves Duchenne muscular dystrophy community reeling, Elevidys use halted in non-ambulatory patients.

Sarepta Therapeutics shares sank to their lowest level in nine years Monday after a second patient taking its Elevidys drug ...

Sarepta Therapeutics said a second patient had died after receiving its $3.2 million gene therapy to treat Duchenne muscular dystrophy.

Shares of Sarepta Therapeutics plunged Monday after the biotech drugmaker reported a second death in connection with its gene therapy for muscular dystrophy.

Sarepta Therapeutics has followed through on its promise to file for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD), as it aims for a launch in the middle ...

The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.

TAS-205 showed no significant impact on motor function in patients with Duchenne muscular dystrophy (DMD), highlighting the ongoing search for effective treatments for the rare condition.

Taiho Pharmaceutical has suffered a blow to its near-term pipeline after a drug candidate for Duchenne muscular dystrophy ...

Sarepta is facing a shareholder lawsuit over ELEVIDYS-related deaths. Robbins LLP cites safety risks and stock losses.

Duchenne Muscular Dystrophy Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook ...