Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Panel to Review Kissei’s Uterine Fibroid Drug, 3 More NMEs on December 3
Japan’s health ministry will convene the Pharmaceutical Affairs Council’s First Committee on Drugs on December 3 to review a slate of products that includes Kissei Pharmaceutical’s uterine fibroid drug linzagolix, known as Yselty overseas. Kissei’s candidate — a GnRH antagonist…
To read the full story
Related Article
- MHLW Panel Green-Lights Approval for Kissei’s Uterine Fibroid Drug, 3 More NMEs
December 4, 2025
- Ultragenyx Japan Seeks Conditional Approval of Triheptanoin for LC-FAOD
August 12, 2025
- Takeda Seeks Pediatric Nod for cTTP Drug Adzynma in Japan
March 28, 2025
- Kissei Files Linzagolix for Uterine Fibroids in Japan
February 27, 2025
- Kerendia Filed for Chronic Heart Failure in Japan: Bayer
February 17, 2025
- Santen Files RVL Pharma’s Droopy Eyelid Drug in Japan
December 27, 2024
REGULATORY
- Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
February 27, 2026
- Japan Panel to Review Joenja, Dojolvi for Approval at March 5 Session
February 27, 2026
- Executives Urge Stronger CDMO, CRO Base at Drug Discovery WG Meeting
February 27, 2026
- Japan to Closely Monitor US “MFN” Policy: PM Takaichi
February 27, 2026
- Japan to Update Adult Pneumococcal Fact Sheet Ahead of Capvaxive NIP Review
February 27, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…