The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
J&J’s Subcutaneous Rybrevant Faces Delay in Japan Approval Process
Japan's approval procedure for Janssen Pharmaceutical’s (J&J) subcutaneous formulation of Rybrevant (amivantamab) has been pushed back after the drug was unexpectedly left off the agenda of a health ministry council meeting this month. The product combines Rybrevant with recombinant hyaluronidase…
To read the full story
Related Article
- Data Error Delayed Japan Review of Subcutaneous Rybrevant; Approval Still Expected This Year
October 30, 2025
- J&J Files for 4-Week SC Dosing of Rybrevant in Japan
October 28, 2025
- Japan Approves Pluvicto, Izervay, and Lots More; Subcutaneous Rybrevant Not on Roster
September 22, 2025
- Novartis’ Radioligand Therapy, More Meds Inch Closer to Japan Approval with Panel OK
August 25, 2025
REGULATORY
- MHLW Issues Guidance on Revised PMD Act Ahead of May Enforcement
January 6, 2026
- MHLW Sets Up Drug Discovery Support Office Ahead of New Fund Launch
January 6, 2026
- Ex-JPMA President Ueno Takes on New AMED Advisor Role
January 6, 2026
- Cabinet OKs FY2026 Tax Reform Package, Creates Strategic Tech R&D Credit
January 5, 2026
- Chuikyo OKs Medical Materials Reform Outline, Price Hikes Possible for Loss-Making Devices
January 5, 2026
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…