Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
6 APIs Including Inebilizumab Designated as Orphan Drugs: MHLW
The Ministry of Health, Labor and Welfare (MHLW) granted orphan drug designation on February 13 for six APIs including Mitsubishi Tanabe Pharma’s humanized anti-CD19 monoclonal antibody inebilizumab. Inebilizumab was designated for an expected indication of prevention of relapse of neuromyelitis…
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REGULATORY
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