Sarepta Therapeutics announced late Friday evening that it will not comply with the Food and Drug Administration's ...

Drugmaker Sarepta Therapeutics said it won’t comply with a request from the FDA to halt all shipments of its gene therapy ...

Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.

Sarepta (SRPT) plans to continue Elevidys shipments for Duchenne muscular dystrophy, despite FDA request not to do so after ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

Recessive dystrophic epidermolysis bullosa (RDEB) is a systemic disease of poor mucocutaneous basement membrane integrity downstream of bi-allelic pathogenic variants in COL7A1. Cutaneous clinical ...

Allegations in the Complaint Sarepta is a biopharmaceutical company focused on genetic medicine, including its gene therapy product ELEVIDYS, developed for the treatment of Duchenne muscular ...

HealthDay News — For patients with recessive dystrophic epidermolysis bullosa (RDEB), a one-time surgical application of prademagene zamikeracel, an autologous COL7A1 gene-modified cellular sheet that ...