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BioPharma Dive3d
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
BioSpace2d
Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...
Sarepta’s Duchenne Therapy Sparked Fears Even Before FDA’s Order
There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.
BioPharma Dive3d
Sarepta stops Elevidys shipments after standoff with FDA
Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...
BioSpace3d
Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...
MPR3d
Third Death Prompts FDA Action on Sarepta’s Gene Therapy Products
The third death occurred in an adult male with limb girdle muscular dystrophy who received a Sarepta AAVrh74 gene therapy product, SRP-9004, in a phase 4 clinical trial.
STAT1mon
Duchenne muscular dystrophy community rocked by Sarepta death | STAT
The death of a second teenage boy from liver failure caused by a gene therapy from Sarepta Therapeutics has left the Duchenne muscular dystrophy community angry, fearful, and divided over ...
Yahoo1mon
Second Duchenne patient dies after receiving Sarepta gene therapy - Yahoo
A second person with Duchenne muscular dystrophy has died after receiving a gene therapy from Sarepta Therapeutics, leading the company to stop treating certain patients with the medicine, known ...
The Boston Globe1mon
Sarepta reports second patient death after treatment with Duchenne gene ...
Sarepta disclosed the first patient death — a 16-year-old boy — in March. Both occurred from acute liver failure, a side effect that has been seen with other gene therapies.
Nasdaq2y
Sarepta Therapeutics Announces Recipients of Route 79, The Duchenne ...
--Sarepta Therapeutics, Inc., the leader in precision genetic medicine for rare diseases, today announced twenty recipients of Route 79, The Duchenne Scholarship Program for the 2022-2023 academic ...