FDA Says It's Investigating Sarepta’s Duchenne Patient Deaths

FDA probes deaths of boys taking Sarepta Duchenne drug

Today's biotech news features an FDA probe into the deaths tied to Sarepta's Duchenne drug, rejecting KalVista's drug application, etc.

FDA Probes Gene Therapy After Two Deaths

(MedPage Today) -- The FDA is investigating the deaths of two boys with Duchenne muscular dystrophy who died soon after being treated with delandistrogene moxeparvovec (Elevidys) gene therapy, the agency said. The investigation will focus on the...

FDA probing deaths with DMD gene therapy Elevidys

The FDA has launched a formal investigation into two liver failure-related deaths in patients treated with Duchenne gene therapy Elevidys.

FDA investigates patient deaths after treatment with Sarepta’s gene therapy

After myriad failures, a new wave of ALS drugs approaches

Several drugmakers anticipate trial results and FDA submissions in 2025 and 2026, including some still overcoming past failures.

FDA investigates patient deaths after treatment with Sarepta's gene therapy

(Reuters) -The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver failure in non-ambulatory Duchenne muscular dystrophy patients after receiving Sarepta Therapeutics' gene therapy, Elevidys.