Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Fuji Pharma/M3’s Dysmenorrhea Drug Filed in Japan, 2024 Rollout Targeted
Fuji Pharma has submitted a new drug application in Japan for its investigational fixed-dose combination agent estetrol/drospirenone (FSN-013) for the treatment of dysmenorrhea, the company and partner M3 said on October 18. The two firms are aiming to introduce the…
To read the full story
Related Article
- Fuji Pharma Kicks Off Japan PIII for Alyssa in Endometriosis
July 28, 2025
- Japan Panel Clears Amgen’s TED Med, Rexulti for Alzheimer’s Agitation and More
August 28, 2024
- Eisai’s ALS Therapy, Amgen’s TED Drug Up for Review on Aug. 26
August 19, 2024
- Fuji Pharma/M3’s Dysmenorrhea Drug Hits Main PIII Goal; 2024 Launch Eyed
February 10, 2023
- Fuji Pharma, M3 Join Hands on Dysmenorrhea Med in Japan
November 13, 2020
BUSINESS
- Astellas Tops 2 Trillion Yen in Sales, Gears Up for Post-Xtandi Growth
April 28, 2026
- Astellas Taps Sanofi Japan Chief Iwaya as Strategy Officer
April 28, 2026
- Teikoku, Curedisc Ink Japan Deal for Disc Herniation Drug
April 28, 2026
- FRONTEO, Science Tokyo Roll Out AI Drug Discovery Hub
April 28, 2026
- Kyorin to Transfer Generics Unit to Daito-Led JV
April 28, 2026
AAV (adeno-associated virus) gene therapies are moving beyond rare diseases into more prevalent conditions, with neovascular, or wet, age-related macular…
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 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…