REGULATORY
US FDA Begins Review of Risks of Serious Bleeding in Patients Taking Dabigatran
The US FDA issued a notification to medical institutions on December 7 saying it was evaluating post-marketing reports of serious bleeding events in patients taking the novel anticoagulant dabigatran (brand name in Japan: Prazaxa). The FDA said it is currently…
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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
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- 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
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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…





