Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Daiichi’s Revised Filing for TROP2 ADC Accepted for FDA Review
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
- FDA Approves Daiichi’s Datroway for EGFR Lung Cancer
June 25, 2025
- Daiichi Sankyo’s Datroway Approved in Europe for Breast Cancer
April 9, 2025
- Dato-DXd Gets EU Panel Backing for Breast Cancer: Daiichi Sankyo
February 4, 2025
- FDA Approves Daiichi’s New ADC Datroway for Breast Cancer
January 21, 2025
- Daiichi, AZ Pull EU Dato-DXd Filing for Lung Cancer
December 25, 2024
- Daiichi Sankyo’s TROP2 ADC Gets Breakthrough Therapy Tag in US
December 10, 2024
- Daiichi Sankyo Replaces FDA Lung Cancer Filing for TROP2-Directed ADC
November 13, 2024
- New Biomarker Analysis Data Out for Daiichi Sankyo’s TROP2 ADC
September 10, 2024
- Daiichi’s TROP2 ADC Accepted for US FDA Review in Breast Cancer
April 3, 2024
- Daiichi Sankyo’s TROP2 ADC Now under Review for Breast Cancer in Japan
March 15, 2024
- EU Regulators Accept Daiichi Sankyo’s TROP2 ADC for Review in Lung, Breast Cancers
March 5, 2024
- Daiichi Sankyo’s TROP2 ADC Now under US FDA Review for Lung Cancer
February 20, 2024
BUSINESS
- China First to Approve Takeda’s Oveporexton for Narcolepsy
July 24, 2026
- Nipro Recalls Febuxostat after Finding Expired API Use at Another Plant
July 23, 2026
- Novo’s Koriyama Plant Achieves Net-Zero CO2 Emissions
July 23, 2026
- Sanofi Files Dupixent for AFRS in Japan
July 23, 2026
- Nippon Shinyaku Licenses NS-025 to US Biotech Aquelys
July 23, 2026
Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
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…