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
Japan Panel to Review Brinsupri, Hyrnuo, Inlexzo, GSK’s Hep B Med on July 27
Quick Look: Three NMEs are up for MHLW panel review on July 27: Insmed’s brensocatib, GSK’s bepirovirsen, and Bayer’s sevabertinib. The session will also cover J&J’s intravesical gemcitabine and BMS’ oral azacitidine, along with label expansions for Rinvoq, Orladeyo, Hympavzi,…
To read the full story
Related Article
- Japan Panel Green-Lights GSK’s Hep B Drug, Brinsupri, Hyrnuo
July 28, 2026
- Avelox Gains Coverage for MDR-TB via Public Knowledge Filing
March 12, 2026
- GSK Files Hep B Drug in Japan as First Global Submission
February 27, 2026
- Regeneron Files Libtayo for Squamous Cell Carcinoma in Japan
December 12, 2025
- Pfizer Files Hympavzi for Hemophilia with Inhibitors
December 11, 2025
- PharmaEssentia Files for ET Indication of Besremi in Japan
September 24, 2025
- AbbVie Japan Seeks Rinvoq Label Expansion for Polyarticular JIA
September 16, 2025
REGULATORY
- MHLW to Discuss Faster MCM Approvals during Health Emergencies
October 26, 2026
- Foreign Price Adjustment Rule a Key Issue in Japan’s MFN Response: Official
October 26, 2026
- MHLW Official Vows Crackdown on Illegal Mounjaro Sales
October 26, 2026
- Temodal, Topotecin Gain NHI Coverage for Neuroblastoma Combo Therapy
October 26, 2026
- Japan Approves OTC Version of Taiho’s Allergy Drug Bilanoa
October 26, 2026





