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 Review for Myocarditis and Other Risks
The Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing the risk of immune thrombocytopenic purpura, myocarditis, and rhabdomyolysis for the immune checkpoint inhibitor Opdivo (nivolumab) - a move that is likely to result in label changes. The PMDA also revealed…
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