Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Shionogi’s Antibiotic Fetroja Now Available in US
Shionogi has launched its novel antibiotic Fetroja (cefiderocol) in the US on February 24 for the treatment of complicated urinary tract infections (cUTI) in patients aged 18 and older who have limited or no alternative options. The drug was approved…
To read the full story
Related Article
- Fetroja Gets FDA’s Priority Review for Nosocomial Pneumonia
June 3, 2020
- Shionogi’s Novel Antibiotic Cefiderocol Approved in Europe
April 30, 2020
- Shionogi’s Fetcroja Bags EU Panel Nod
March 4, 2020
- Shionogi Wins US Approval for Antibiotic Fetroja
November 18, 2019
- US FDA Panel Backs Shionogi’s Novel Antibiotic
October 18, 2019
- Novel Antibiotic Cefiderocol Meets Primary Endpoint in Global PIII: Shionogi
October 4, 2019
- Novel Antibiotic Cefiderocol Accepted for EMA Review: Shionogi
April 2, 2019
BUSINESS
- FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
March 12, 2026
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
- Lotte to Step Up CVC Investments to Drive CDMO Synergies
March 10, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…