Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
MHLW Orders Label Revision for Elevidys to Add Acute Hepatic Failure
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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