Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Padcev/Keytruda Label Expansion Accepted for US FDA Review
Astellas Pharma said on October 21 that the US FDA has accepted for review an application seeking to broaden the label of its antibody drug conjugate (ADC) Padcev (enfortumab vedotin), which the company co-develops with Pfizer, in combination with Merck’s…
To read the full story
Related Article
- Astellas, MSD File Padcev-Keytruda for Cisplatin-Eligible MIBC in Japan
May 15, 2026
- Astellas, MSD Seek Japan Nod for Padcev/Keytruda in Perioperative MIBC
February 2, 2026
- Padcev-Keytruda Pair Makes Mark in Cisplatin-Eligible MIBC: Astellas
December 19, 2025
- Padcev/Keytruda Wins US Nod for Perioperative Bladder Cancer Use
November 26, 2025
- Padcev-Keytruda Combo Delivers Positive PIII Data in Bladder Cancer
August 18, 2025
BUSINESS
- Boehringer’s Japan Pharma Sales Up for 7th Straight Year, 10-Plus Launches Eyed by 2030
June 4, 2026
- Sato Bets on Solo Nailin Promotion, Hospital Push to Drive Dermatology Growth
June 4, 2026
- Nitrosamine Detected in Viatris’ Jzoloft OD Tablets
June 4, 2026
- RaQualia, RIKEN Team Up on Drug Discovery Technologies
June 4, 2026
- AbbVie Japan Says Sales-Doubling Plan on Track as Revenue Climbs 13.5%
June 3, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…