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Exclusive-US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy ...
BioPharma Dive3m
FDA to ask Sarepta to stop shipping Duchenne gene therapy
The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the ...
Patient Deaths Linked to Sarepta Gene Therapy Prompt FDA Probe
The head of the US Food and Drug Administration said the agency will “take a hard look” at a gene therapy from Sarepta ...
Sarepta plunges as FDA is reportedly evaluating if gene therapy should remain on market
Sarepta Therapeutics (SRPT) stock falls as the FDA reviews if the company's gene therapy Elevidys should remain on the market following patient deaths. Read more here.
STAT47m
FDA to request Sarepta Therapeutics halt shipments of Duchenne gene therapy
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
Sarepta Therapeutics, Inc. (SRPT) Strategic Restructure and ELEVIDYS Label Update Call Transcript
Good morning, and welcome to Sarepta's Conference Call to discuss the Update on Strategic Restructure and ELEVIDYS Label. As a reminder, today's program is being recorded. At this time, I'll turn the ...