Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Kura/Kyowa Kirin’s AML Drug Accepted for US FDA Review
Kura Oncology and Kyowa Kirin said that the US FDA has accepted for priority review the companies’ investigational acute myeloid leukemia (AML) treatment ziftomenib, with the target action date set for November 30. A selective once-daily oral menin inhibitor, ziftomenib…
To read the full story
Related Article
- Kura, Kyowa Kirin Land US FDA Approval for AML Med Komzifti
November 17, 2025
- Ziftomenib Given in New AML Cohort in US PI Trial: Kura/Kyowa Kirin
October 3, 2025
- Kura/Kyowa Kirin’s AML Drug Inches Closer to FDA Filing on Positive PII Data
February 7, 2025
- Kyowa Kirin, Kura Form Global Collab on Leukemia Drug
November 22, 2024
BUSINESS
- Pharma Earnings Season Kicks Off; Off-Year Impact, Overseas Trends in Focus
April 24, 2026
- Gilead Files Trodelvy-Keytruda Combo for 1L TNBC in Japan
April 24, 2026
- Co-Promotions Dominate in Oncology, Diabetes Alliances: Fuji Keizai
April 24, 2026
- Medii, Pediatric Neurology Society Build System to Support Elevidys Use
April 24, 2026
- Oncolys’ OBP-301 Wins US Fast Track Designation
April 24, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…