Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
FDA Accepts BridgeBio’s Infigratinib NDA for Achondroplasia
BridgeBio Pharma said on October 6 that the US FDA has accepted its new drug application for oral infigratinib for children with achondroplasia and granted a priority review, with a target action date of February 4, 2027. The US biotech…
To read the full story
Related Article
- Kyowa Kirin Begins Japan PIII Trial of Infigratinib for Achondroplasia
November 25, 2025
- Kyowa Kirin Snares Japan Rights to BridgeBio’s Skeletal Dysplasias Drug
February 8, 2024
BUSINESS
- Parexel Revs Up AI Drive, Targets 6-Month Trial Time Cut
October 8, 2026
- FDA Accepts BridgeBio’s Infigratinib NDA for Achondroplasia
October 8, 2026
- Eylea 8 mg Shows Vision Gains in 24-Week Analysis
October 8, 2026
- Boehringer, Hiroshima Tie Up on Health Promotion
October 8, 2026
- Japan Ethical Drug Sales Up 3% in August: Crecon
October 8, 2026
Japan’s plasma-derived product industry is approaching a turning point as the government prepares to step in with unprecedented support for…
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…
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…