News

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...
BioSpace1d
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, ...
BioSpace1d
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 ...
Southwest Journal5d
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
Devdiscourse1d
Health and Innovation: Elderly Fitness, Corporate Battles, and Medical Advances
Recent developments in the health sector include fitness classes helping Ugandan women fight noncommunicable diseases, Humana's legal challenge to US Medicare star ratings downgrades, Sarepta pausing ...
STAT5h
Roche halts some shipments of Sarepta’s Duchenne gene therapy outside U.S.
Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...
BioPharma Dive1d
FDA asks Sarepta to stop shipping Duchenne gene therapy
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
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 Dive1d
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" ...
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, ...
Precision Medicine Online23h
Sarepta to Now Voluntarily Pause Shipments of Elevidys Duchenne Gene Therapy
The FDA had made the request Friday, which Sarepta initially rebuffed, following the death of a third patient treated with one of the firm's gene therapies.