Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Panel to Review Joenja, Dojolvi for Approval at March 5 Session
Quick Look: Three NMEs are set for approval review by an MHLW panel on March 5: OrphanPacific’s leniolisib, Ultragenyx’s triheptanoin, and Bayer’s gadoquatrane. The agenda also includes label expansions for Lusefi and Effexor, a new Eylea biosimilar from Celltrion, and…
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