News

MIT Technology Review23h
The deadly saga of the controversial gene therapy Elevidys
The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
FDA Probes Death of Boy in Brazil on Sarepta’s Elevidys
US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.
Roche Says CHMP Issued a Negative Opinion on the Conditional Marketing Authorisation for Elevidys
Dow Jones Newswires is a market-moving financial and business news source, used by wealth managers, institutional investors and fintech platforms around the world to identify trading and investing ...
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...
Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths
The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...
Roche Pauses Commercial and Clinical Use of Elevidys After Fatal Liver Failures
The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.
Explore more
EU regulator does not recommend approval of Sarepta's muscle disorder gene therapy
Europe's medicines regulator did not recommend the approval of Sarepta Therapeutics' gene therapy Elevidys for a type of rare ...
Sarepta’s Elevidys Halted at Children’s Hospital Los Angeles
Children’s Hospital Los Angeles paused the use of Sarepta Therapeutics Inc.’s gene therapy for Duchenne muscular dystrophy in the wake of rising safety concerns about liver toxicity, adding to ...