Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Rejects Astellas’ Gastric Cancer Med over Manufacturing Issues
Astellas Pharma said on January 9 that the US FDA has declined to approve zolbetuximab, a first-in-class Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody filed for the treatment of certain patients with gastric cancer, due to manufacturing issues. The agency issued a…
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