Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Enhertu Now under US Review for Post-Neoadjuvant HER2 Breast Cancer
Daiichi Sankyo said on March 9 that the US FDA has accepted for review a supplemental biologics license application for its anti-HER2 antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) seeking a new indication in HER2-positive early breast cancer. The company…
To read the full story
Related Article
- Enhertu Filed in Japan as Adjuvant Therapy for Early Breast Cancer
March 2, 2026
- Enhertu Accepted for EU Review in Post-Neoadjuvant HER2 Breast Cancer
February 20, 2026
- Enhertu Wins US Breakthrough Tag in Post-Neoadjuvant HER2 Breast Cancer
December 23, 2025
BUSINESS
- J&J's Drug-Device Combo Offers Weeks-Long Local Therapy for Bladder Cancer: Exec
May 8, 2026
- Leqembi FY2025 Global Sales Reach 88 Billion Yen: Eisai
May 1, 2026
- Rohto Files CMV Corneal Endotheliitis Drug in Japan
May 1, 2026
- Mochida Files in Japan for PAH Drug Tyvaso DPI
May 1, 2026
- Tanabe Clinches EU Approval for Parkinson’s Drug Onerji
May 1, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…