The Ministry of Health, Labor and Welfare (MHLW) on October 18 ordered Ono Pharmaceutical to revise the label for its immune checkpoint inhibitor Opdivo (nivolumab) to add immune thrombocytopenic purpura (ITP) as a clinically significant adverse drug reaction (ADR). In…
To read the full story
Related Article
- Opdivo under PMDA Review for Myocarditis and Other Risks
September 26, 2016
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…





