Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Approves Batch of New Drugs, Subcutaneous Rybrevant Finally Cleared
Japan’s Ministry of Health, Labor and Welfare (MHLW) granted regulatory approvals for a long list of new medicines and label expansions on December 22. The roster includes Janssen Pharmaceutical’s (J&J) Rybrofaz (amivantamab + vorhyaluronidase alfa), a subcutaneous formulation of Rybrevant…
To read the full story
Related Article
- Blenrep, Monjuvi, Zynyz, and More New Drugs Hit Japan Market
March 19, 2026
- Chuikyo OKs Listing of J&J’s Rybrofaz, Peak Sales Seen at 43.8 Billion Yen
March 12, 2026
- GSK’s Exdensur, Lilly’s Inluriyo Missing from March Listing Roster
March 12, 2026
- MHLW Panel Green-Lights Approval for Kissei’s Uterine Fibroid Drug, 3 More NMEs
December 4, 2025
- Japan Panel Clears KalVista’s HAE Drug, GSK’s Asthma Agent, and More for Approval
November 28, 2025
- Shionogi/Sage’s Zurzuvae Clears MHLW Panel, Label Wording on Combo Use under Review
October 31, 2025
- Data Error Delayed Japan Review of Subcutaneous Rybrevant; Approval Still Expected This Year
October 30, 2025
REGULATORY
- LDP Project Team Flags Drug Pricing as Key to Investment
March 19, 2026
- Japan Sets Up Radiopharma Discovery Hub in Fukushima, Targets Rare Cancers
March 18, 2026
- MHLW Seeks Industry Survey on Petroleum-Linked Products amid Iran Crisis
March 18, 2026
- MHLW Orders Label Revisions for Antiepileptics and Other Drugs
March 18, 2026
- MHLW Panel OKs Draft Criteria for “Specified Medical Technologies”
March 17, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…