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Drugmaker Sarepta Therapeutics says it won't comply with a request from U.S. regulators to halt all shipments of its gene ...
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 ...
The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed ...
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 ...
ELEVIDYS is a prescription gene therapy intended for a limited category of people with Duchenne. For more information, submit a form, email attorney Aaron Dumas, Jr., or give us a call at (800 ...
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 ...
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