Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Opdivo under PMDA Risk Review for Fulminant Hepatitis
The Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing a new adverse reaction risk of fulminant hepatitis for Ono Pharmaceutical’s PD-1 inhibitor Opdivo (nivolumab), a move that is likely to result in label revisions, according to the agency’s risk communication…
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REGULATORY
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