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 ...
pharmaphorum15d

Taiho's late-stage Duchenne candidate fails trial

Taiho Pharmaceutical has suffered a blow to its near-term pipeline after a drug candidate for Duchenne muscular dystrophy (DMD) missed the mark in a phase 3 trial.
BioPharma Dive12d

FDA turns back Capricor’s Duchenne cell therapy

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...
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.
FiercePharma28d

FDA investigates patient deaths after treatment with Sarepta's Duchenne ...

Sarepta reported the deaths in March and on June 16. Both patients were teenage boys who passed away after developing acute liver failure within two months after treatment with Sarepta’s one ...
The Business Journals29d

FDA says it's investigating Sarepta’s Duchenne patient deaths

Sarepta Therapeutics' headquarters at 215 First St. in Cambridge. The FDA is conducting an investigation following the deaths of two patients treated with Sarepta’s gene therapy for Duchenne ...