Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan OKs Zolgensma Intrathecal Form, Breyanzi Expansion, New EB Therapy
Japan granted three regenerative medicine approvals on April 3 including a new intrathecal formulation of Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec), along with a label expansion for Bristol Myers Squibb’s CAR-T therapy Breyanzi (lisocabtagene maraleucel). The intrathecal version of Zolgensma…
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