Daiichi Sankyo’s Enhertu Wins CDE Acceptance for First‑Line HER2‑Positive Breast‑Cancer Indication in China
Daiichi Sankyo Co., Ltd. (TYO: 4568) announced that China’s Center for Drug Evaluation (CDE) of...
Daiichi Sankyo
AstraZeneca & Daiichi Sankyo Announce 11.2% pCR Gain with Enhertu in DESTINY‑Breast11 at ESMO 2025
AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) disclosed the Phase III DESTINY‑Breast11 results at...
AstraZeneca and Daiichi Sankyo Submit Priority‑Review sBLA for Enhertu as First‑Line Therapy for HER2‑Positive Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have filed a supplemental Biologics License...
Daiichi Sankyo’s Enhertu Submitted for Priority Review in China for HER2-Positive Breast Cancer
On August 22, 2025, Daiichi Sankyo (TYO: 4568) submitted a marketing authorization application for Enhertu...
DATROWAY Approved in China for HR-Positive, HER2-Negative Breast Cancer
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) announced that DATROWAY has been approved...
Hengrui’s Trastuzumab Rezetecan Granted FDA Orphan Drug Designation for Gastric Cancer Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that it has received...
Daiichi Sankyo and AstraZeneca Submit Enhertu Application for HER2-Positive Gastric Cancer in China
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have submitted a supplemental new-drug application...
FDA Approves AstraZeneca’s Datopotamab deruxtecan for EGFR-Mutated NSCLC
The US Food and Drug Administration (FDA) this week approved Datopotamab deruxtecan (Dato-DXd), a TROP-2-targeted...
Daiichi Sankyo Launches Phase I Trial for Enhertu Subcutaneous Formulation
Japan-based Daiichi Sankyo (TYO: 4568) has registered a Phase I clinical trial on ClinicalTrials.gov for...
MSD and Daiichi Sankyo Withdraw US Filing for Patritumab Deruxtecan in EGFR-Mutated NSCLC
Partners Merck, Sharp & Dohme (MSD; NYSE: MRK) and Daiichi Sankyo (TYO: 4568) announced the...
Merck Sharp & Dohme Initiates Phase III Trial of Ifinatamab Deruxtecan for Esophageal Cancer
US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) announced the first patient dosing in...
AstraZeneca and Daiichi Sankyo Announce Positive DESTINY-Breast11 Trial Results for Enhertu
Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced the positive preliminary results from...
Roche’s VENTANA TROP2 Device Receives FDA Breakthrough Designation
Swiss giant Roche AG (SWX: ROG, OTCMKTS: RHHBY) announced that its VENTANA TROP2 (EPR20043) RxDx...
Enhertu Approved by EC for Earlier-Line Treatment of HR+/HER2-low Breast Cancer
Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that they have received approval...
Daiichi Sankyo Launches Datroway in Japan for HR Positive, HER2 Negative Breast Cancer
Japan-based Daiichi Sankyo (TYO: 4568) has announced the launch of Datroway (datopotamab deruxtecan) in Japan....
AstraZeneca and Daiichi Sankyo’s Enhertu Shows Positive Results in Phase III Study
Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced positive topline results from the...
Daiichi Sankyo Reports 16.6% Revenue Growth in First Three Quarters of FY2024
Japan-based Daiichi Sankyo (TYO: 4568) has reported revenues of JPY 1.37 trillion ($8.927 billion) for...
Enhertu Approved by FDA for HR-Positive, HER2-Low Breast Cancer
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) jointly announced that their co-developed antibody-drug...
FDA Approves Datroway for HR+/HER2- Breast Cancer Treatment
Datroway (datopotamab deruxtecan-dlnk, Dato-Dxd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate co-developed by Japan-based Daiichi...
Daiichi Sankyo Acquires Gatipotuzumab IP Rights for $132.5M
Japan-based Daiichi Sankyo Company, Ltd (TYO: 4568) has announced an investment of USD 132.5 million...