REGULATORY

MHLW Orders Label Revision for Elevidys to Add Acute Hepatic Failure

September 1, 2025
The Ministry of Health, Labor and Welfare (MHLW) on August 28 ordered a label change for Chugai Pharmaceutical’s Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec), adding acute hepatic failure as a serious adverse reaction following reports of fatal cases…

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