Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Sakigake Status Awarded to GSK’s Next-Gen I/O Therapy, 2 More Drugs; System Possibly Subject to Review Next Time
The Ministry of Health, Labor and Welfare (MHLW) on June 19 announced the fifth batch of products that have been granted sakigake fast-track designation, the Japan equivalent of the US FDA’s Breakthrough Therapy status, which include GlaxoSmithKline’s next-generation immuno-oncology therapy…
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REGULATORY
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