Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW OKs Opdivo’s Add’l Indications and Flat Dose, 1st-Line Tagrisso Use and More
The Ministry of Health, Labor and Welfare (MHLW) approved a series of new indications on August 21, including a label expansion and dosage change for Opdivo (nivolumab), as well as the first-line use of Tagrisso (osimertinib) in non-small cell lung…
To read the full story
Related Article
- MHLW Panel Backs Lilly’s Ibrance Contender Abemaciclib for Breast Cancer
August 6, 2018
- Boehringer’s DPP-4/SGLT2 Combo Clears MHLW Panel
July 30, 2018
REGULATORY
- Update: DMD Gene Therapy Elevidys Cleared for NHI Listing at 305 Million Yen
February 13, 2026
- MHLW Orders Label Revisions for Vyxeos, Inlyta, Imbruvica, and More Drugs
February 13, 2026
- MHLW Orders Label Revisions for Sulfite-Containing Medical Products
February 13, 2026
- PMDA Urges Proper Use of Colchicine, Advises against High-Dose Administration
February 12, 2026
- PMDA to Offer Priority Consultations for Overseas Startups
February 12, 2026
Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…