Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan Panel Clears KalVista’s HAE Drug, GSK’s Asthma Agent, and More for Approval
A Japanese health ministry panel on November 27 endorsed approvals for seven new molecular entities (NMEs) — including KalVista Pharmaceuticals’ on-demand hereditary angioedema (HAE) therapy sebetralstat, known overseas as Ekterly. The Pharmaceutical Affairs Council’s Second Committee on Drugs backed sebetralstat,…
To read the full story
Related Article
- Japan Approves Batch of New Drugs, Subcutaneous Rybrevant Finally Cleared
December 23, 2025
- Nipro-Samsung Alliance Nears First Approval in Japan with Stelara Biosimilar
November 14, 2025
- Japan Panel to Review KalVista’s Oral HAE Drug, GSK’s Asthma Med, and More on Nov. 27
November 14, 2025
- Tecentriq Filed for Thymic Carcinoma in Japan: Chugai
May 15, 2025
- Nippon Shinyaku Files BPDCN Drug in Japan
March 31, 2025
- Sanofi Japan Files Dupixent for Asthma in Children Aged 6-11
February 12, 2025
- GSK Files Depemokimab for Asthma and CRSwNP in Japan
January 29, 2025
- KalVista Files HAE Drug Sebetralstat in Japan
January 29, 2025
REGULATORY
- Japan Panel Again Defers Male HPV Shots amid Cost-Effectiveness Concerns
October 9, 2026
- Takaichi Defends Off-Year Drug Price Revisions as DPP Calls for Abolition
October 9, 2026
- Japan Orders Contraindication for Adlumiz-Noxafil Combination
October 9, 2026
- Imcivree, Hibsago Get Chuikyo Nod for Home Self-Injection
October 9, 2026
- Provider-Payer Tug-of-War Takes Shape over FY2027 Drug Price Revision
October 8, 2026
Japan’s plasma-derived product industry is approaching a turning point as the government prepares to step in with unprecedented support for…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…