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
US FDA Issues Warning Letter Over GMP Violations by Daiichi Sankyo Subsidiary
The US Food and Drug Administration (FDA) has issued a warning letter to Luitpold Pharmaceuticals Inc., a US subsidiary of Daiichi Sankyo, regarding what it calls “significant” GMP violations at a New York manufacturing facility. The letter was made public…
To read the full story
REGULATORY
- 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
- LDP Lawmakers Renew Push for Routine HPV Shots for Males by April 2027
October 27, 2026





