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 Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
A key Japanese health ministry panel on March 4 gave the thumbs-up to the approval of Astellas Pharma’s zolbetuximab, a first-in-class anti- Claudin 18.2 (CLDN18.2) monoclonal antibody, two months after the US FDA declined its application over manufacturing issues. Zolbetuximab…
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