FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures
Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels
Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels
Elevidys is currently the only approved gene therapy that targets the root cause of Duchenne
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
Subscribe To Our Newsletter & Stay Updated