REGULATORY
MHLW Orders Label Revisions for Vyxeos, Inlyta, Imbruvica, and More Drugs
Japan’s Ministry of Health, Labor and Welfare (MHLW) on February 10 ordered safety-related label revisions for a range of medicines, including Nippon Shinyaku’s high-risk acute myeloid leukemia treatment Vyxeos (cytarabine + daunorubicin). For Vyxeos, the ministry instructed the addition of…
To read the full story
Related Article
- MHLW to Ease Uniform Driving Restrictions on Oral Antiepileptics
January 29, 2026
- Antivirals, Cancer Drugs Flagged in PMDA Risk Review
January 19, 2026
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…





