Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Daiichi’s TROP2 ADC Accepted for US FDA Review in Breast Cancer
Daiichi Sankyo said on April 2 that the US FDA has accepted for review a regulatory application for datopotamab deruxtecan (Dato-DXd), a TROP2 directed antibody drug conjugate (ADC), for the treatment of certain breast cancer patients. The submission seeks the…
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’s Revised Filing for TROP2 ADC Accepted for FDA Review
January 15, 2025
- Daiichi, AZ Pull EU Dato-DXd Filing for Lung Cancer
December 25, 2024
- Daiichi Sankyo Replaces FDA Lung Cancer Filing for TROP2-Directed ADC
November 13, 2024
- Daiichi Sankyo’s TROP2 ADC Misses OS Goal in Breast Cancer Trial
September 25, 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
- Pfizer Brings Eisai into Nurtec Promotion in Japan
July 28, 2026
- Celltrion, Nippon Kayaku Broaden Alliance in Biopharma Biz
July 28, 2026
- Ishin Eyes Domestic Production of Allostem by August 2028
July 28, 2026
- Enhertu Combo Bags EU Panel Nod in 1st-Line HER2 Breast Cancer
July 28, 2026
- FDA Approves Otsuka’s ADHD Drug Simtriyo
July 28, 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…