BUSINESS

Daiichi’s Revised Filing for TROP2 ADC Accepted for FDA Review

January 15, 2025
Daiichi Sankyo said on January 13 that the US FDA has accepted for review its revised filing for datopotamab deruxtecan (Dato-DXd), a TROP2-targeted antibody drug conjugate (ADC), for the treatment of EGFR-mutated lung cancer. The submission seeks the FDA nod…

To read the full story

Related Article

BUSINESS

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Tatsuya Otsuka

Japan’s biotech startups are coming under growing pressure as the Tokyo Stock Exchange (TSE) tightens its rules for companies listed…

By Philip Carrigan

The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

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…