Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Paper Retraction Won’t Impact Zolgensma Japan Approval, Data Deleted from Label
Japanese approval for Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) will remain intact despite the recent retraction of a 2010 paper featuring animal study data on the treatment, with regulators upholding their assessment for efficacy and safety. The Ministry of Health,…
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REGULATORY
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