REGULATORY
Japan Approves Keytruda’s 1st Line RCC, Head and Neck Cancer Use, Bavencio’s Label Expansion and More
The Ministry of Health, Labor and Welfare (MHLW) approved a batch of new indications on December 20, including first-line use in advanced renal cell carcinoma (RCC) for the immune checkpoint inhibitors Bavencio (avelumab) and Keytruda (pembrolizumab), with the MSD drug…
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REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





