Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Keytruda SC Heads to Japan Approval, Ipsen’s Ojemda for Conditional Nod
A key Japanese health ministry panel on August 24 recommended approval of a batch of new medicines and indications including a subcutaneous version of MSD’s PD-1 inhibitor Keytruda (pembrolizumab) and Ipsen’s targeted glioma therapy tovorafenib, known as Ojemda. The Pharmaceutical…
To read the full story
Related Article
- Japan Doles Out Orphan Tags to Givinostat, Apitegromab, and Lots More
September 28, 2026
- Japan Approves Keytruda, Leqembi SC Formulations, Xcopri, and More Drugs
September 17, 2026
- Japan Panel to Weigh Keytruda SC, J&J Psoriasis Pill among 6 NMEs on Aug. 24
August 18, 2026
- Datroway Filed for 1st-Line TNBC in Japan: Daiichi Sankyo
February 13, 2026
- J&J Files Tecvayli/Darzquro Combo for MM in Japan
February 12, 2026
- Ohara Files Japan NDA for Jazz’s Diffuse Midline Glioma Drug
February 2, 2026
- Takeda Files ImmunoGen-Paired ADC for Ovarian Cancer in Japan
February 2, 2026
- Japan Panel Green-Lights Pfizer’s Tukysa, Wider Labels for Tezspire, and More Drugs
January 30, 2026
- J&J Files Oral Psoriasis Drug Icotrokinra in Japan
November 10, 2025
- MSD Seeks Capvaxive Use in High-Risk Children in Japan
November 10, 2025
- MSD Files for Keytruda Label Expansion in Ovarian Cancer
October 31, 2025
- AbbVie Files Skyrizi for Pediatric Dosage in Japan
October 30, 2025
- Enhertu Combo Filed for First-Line HER2 Breast Cancer in Japan
October 8, 2025
REGULATORY
- Japan Has Limited Drug Pricing Cards to Play on MFN, Should Expand CEA: MOF Official
October 5, 2026
- No Financial Aid Planned for OTC-Like Drug Charge System Changes: Ueno
October 5, 2026
- Leustatin Label to Warn Against Breastfeeding for 7 Days after Treatment
October 5, 2026
- US Narrows Scope of Medicare MFN Model, Exempts Orphan-Only Drugs
October 2, 2026
- Japan to Draw Up Growth Strategy Action Plan by Year-End
October 2, 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…