The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Japan Panel OKs Taisho’s Insomnia Med, 2 Other NMEs for Approval
A Japanese health ministry panel on July 31 endorsed a batch of new drugs and label expansions for regulatory approval, among them three new molecular entities (NMEs), including Taisho Pharmaceutical’s in-house developed vornorexant. The Pharmaceutical Affairs Council’s First Committee on…
To read the full story
Related Article
- Japan Approves 3 New Drugs, Expands Label for Enhertu, Silgard 9 and More
August 26, 2025
- Santen’s Glaucoma Drug, Taisho’s Insomnia Med Up for Panel Review on July 31
July 25, 2025
- Teijin Seek Japan Approval for Ascendis’ Hypoparathyroidism Drug
December 16, 2024
- Santen Files Glaucoma Drug Sepetaprost in Japan
September 27, 2024
- Taisho Seeks Japan Nod for Insomnia Med Vornorexant
September 13, 2024
REGULATORY
- Japan Puts CEA Expansion on Hold, Sets 6-Month “Technical Discussions”
December 26, 2025
- Gist of FY2026 Drug Pricing Reform Outline
December 26, 2025
- Chuikyo OKs FY2026 Drug Pricing Reform Outline, Scraps “Spillovers” but Adds New Follow-Up Rules
December 26, 2025
- Japan Cabinet OKs Record Social Security Spending in FY2026 Budget, 105 Billion Yen in Drug Price Cuts
December 26, 2025
- MHLW Names 77 Active Ingredients for OTC-Like Drug Charges
December 26, 2025
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
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…