Quick Look: An MHLW panel recommended approval for three NMEs on March 5: OrphanPacific’s leniolisib, Ultragenyx’s triheptanoin, and Bayer’s gadoquatrane. The session also supported label expansions for Lusefi and Effexor, while the ministry reported plans to approve Celltrion’s Eylea biosimilar…
To read the full story
Related Article
- Japan Panel to Review Joenja, Dojolvi for Approval at March 5 Session
February 27, 2026
- Celltrion Files Biosimilar without Japanese Clinical Data, More Firms Might Follow
October 24, 2025
- Ultragenyx Japan Seeks Conditional Approval of Triheptanoin for LC-FAOD
August 12, 2025
- Bayer Files Low-Dose MRI Contrast Agent Gadoquatrane in Japan
June 3, 2025
- Bayer Files Eylea 8 mg for Macular Edema following RVO in Japan
May 13, 2025
- Lusefi Filed for Pediatric Use in Japan: Taisho
May 13, 2025
- Effexor Filed for Generalized Anxiety Disorder in Japan: Viatris
April 22, 2025
REGULATORY
- Avastin Price to Be Axed by 45% as G1 Rule Hits Originator Biologics
March 6, 2026
- Forxiga Slapped with 36% Price Cut on PMP Return in FY2026 Revision
March 6, 2026
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Japan's Revised Drug Distribution Guidelines Take Effect
March 6, 2026
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





