Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
MHLW Panel Green-Lights Approval for Kissei’s Uterine Fibroid Drug, 3 More NMEs
A Japanese health ministry panel on December 3 gave its blessing to four new molecular entities (NMEs) — including Kissei Pharmaceutical’s uterine fibroid drug linzagolix, known as Yselty overseas. The Pharmaceutical Affairs Council’s First Committee on Drugs endorsed approval for…
To read the full story
Related Article
- Japan Approves Batch of New Drugs, Subcutaneous Rybrevant Finally Cleared
December 23, 2025
- MHLW Panel to Review Kissei’s Uterine Fibroid Drug, 3 More NMEs on December 3
November 21, 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
- CEA Review Has not Settled Debate, LDP Lawmaker Says
September 15, 2026
- Japan Pharma Investment Subgroup to Hold 1st Meeting September 18
September 14, 2026
- Japan Formally Joins Project Orbis for Cancer Drug Reviews
September 14, 2026
- MHLW Seeks 20.6 Billion Yen for MCM Stockpiles, Revenue Guarantees
September 14, 2026
- Japan Panel Backs Mandatory Medical Data Sharing by Major Hospitals
September 14, 2026
Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…