Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan OKs Bayer’s MRI Agent, Haihe’s PI3Kα Med, Enhertu’s Tumor-Agnostic Use, and More
Japan granted regulatory approvals for a throng of new medicines and label expansions on March 23, including Bayer’s low-dose MRI contrast agent Ambelvist (gadoquatrane) and Haihe Biopharma’s PI3Kα inhibitor Haizexin (risovalisib). The Ministry of Health, Labor and Welfare (MHLW) gave…
To read the full story
Related Article
- Sarclisa SC, Joenja, Kineret, and 7 More Drugs Bound for NHI Listing
August 6, 2026
- Boehringer’s Big-Seller Hopeful Jascayd Set for Listing, Haihe’s Haizexin Too
July 9, 2026
- Japan to List 1st Biosimilars for Xolair, Ranmark, Simponi on May 20
May 19, 2026
- Japan OKs Listing of Ambelvist, Dojolvi, Sohonos, and Finally Inrebic
May 14, 2026
- Celltrion Wins First Xolair Biosimilar Approval in Japan, Targets May Listing
March 24, 2026
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Japan Panel Backs Daiichi’s MMR Vaccine, Haihe’s PI3Kα Inhibitor, MSD’s HIV Med
March 3, 2026
REGULATORY
- Chuikyo Backs Broader CEA Price Cuts This Year, Snubs Pharma Plea
October 1, 2026
- Repatha Optimal Use Guidelines to Be Simplified
October 1, 2026
- Label Revisions Ordered for Checkpoint Inhibitors over Gastritis, Esophagitis
September 30, 2026
- MHLW Panel Backs Easing Protopic Contraindication for Young Children
September 30, 2026
- PMDA Flags New Safety Risks with 3 Drugs
September 30, 2026
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…
The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…
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…