News

Gene Therapy Maker Sarepta Tells FDA It Won't Halt Shipments Despite Patient Deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
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 ...
Sarepta shares plunge 40% as future of its gene therapy appears at risk
Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk.
Fierce Pharma29m
Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
BioSpace11h
How Data Secrecy Is Stalling Progress in Cell and Gene Therapy
Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy ...
GEN - Genetic Engineering and Biotechnology News3h
FDA Grants Regenerative Medicine Advanced Therapy Designation to Gene Therapy for Osteoarthritis
IL-1 is considered one of the key mediators involved in the pathogenesis of OA, causing inflammation, joint pain, and ...
Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request
When three patients die after taking a cutting-edge drug, most companies hit the brakes. Not Sarepta Therapeutics. The ...
FDA Places Sarepta's Investigational Gene-Therapy Trials on Hold Following Patient Death
Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was ...
Sarepta's Setback Deepens With Another Gene Therapy Fatality
Sarepta's gene therapy pipeline faces renewed scrutiny after a third patient death and FDA plans for a black box warning on ...