PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
REGULATORY
PFSB Issues Director Notification Calling for Revision of Package Inserts for Products Including Kiklin, Stivarga
The Pharmaceutical and Food Safety Bureau’s (PFSB) Safety Division issued a director notification to the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) on February 18 calling for the revision of package inserts for the hyperphosphatemia treatment bixalomer (Astellas Pharma’s…
To read the full story
REGULATORY
- Zolgensma Cost-Effectiveness Analysis to Resume after Five-Year Halt
October 29, 2026
- Japan Eyes Priority Review for MCMs, Bill Submission Planned for 2027
October 28, 2026
- Panel Member Urges Review of Tavneos Blue Letter Timing
October 28, 2026
- Japan Orders Label Revisions for Leqvio, Amenalief, 2 Other Drugs
October 28, 2026
- AbbVie’s Fast-Acting Botulinum Toxin Boey Wins Japan Panel Backing
October 27, 2026





