AstraZeneca, FDA and ENHERTU

AstraZeneca, Daiichi Sankyo win first U.S. approval for key cancer drug
A drug from AstraZeneca and Daiichi Sankyo won authorization for a form of breast cancer, the first U.S. approval for the closely watched treatment.
AstraZeneca's Enhertu gets additional FDA approval
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's (OTCPK:DSKYF) drug Enhertu has been approved by the FDA for the treatment of certain breast cancer patients. Enhertu was approved for the treatment of unresectable or metastatic HR-positive,
FDA Approves AstraZeneca And Daiichi Sankyo's ENHERTU For HER2-Low/Ultralow Breast Cancer
The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU
AstraZeneca Receives FDA Approval for Enhertu Breast Cancer Treatment
AstraZeneca received Food and Drug Administration approval for enhertu, its breast cancer treatment developed in partnership with Japanese company Daiichi Sankyo.
FDA Approves AstraZeneca, Daiichi Sankyo’s Datroway for Previously Untreated Unresectable, Metastatic HR-Positive, HER2-Negative Breast Cancer
Approval is based on results from the TROPION-Breast01 Phase III trial, in which Datroway demonstrated a significant reduction in the risk of disease progression or death in patients with previously treated,
AstraZeneca/Daiichi Sankyo survey reveals breast cancer misconceptions in Europe
A new European survey sponsored by AstraZeneca (AZ) and Daiichi Sankyo has revealed widespread misconceptions about breast cancer and metastatic cases of the disease.
AZ, Daiichi get FDA nod for Dato-DXd in breast cancer
The US regulator has cleared TROP2-directed ADC datopotamab deruxtecan (Dato-DXd) under the Datroway trade name as a treatment for previously treated HR+/HER2- breast cancer, a few weeks after its first world approval in Japan.
Daiichi Sankyo rises most in five months on cancer drug approval
Drugmaker Daiichi Sankyo has risen the most in five months after its novel breast cancer treatment won U.S. approval, a milestone in the company’s efforts to turn it into a widely used blockbuster. The stock climbed as much as 8% in early morning trading in Tokyo on Monday, the largest intraday gain since Aug. 6.
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Daiichi Sankyo Admits 2024 Wasn’t ‘Perfect’ but 2025 Is Starting Off With a Bang
The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this ...
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Daiichi Sankyo buys solid tumour ADC from Glycotope for $132.5m
Daiichi Sankyo has finalised the acquisition of intellectual property rights for gatipotuzumab, an anti-tumour-associated ...
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AstraZeneca and Daiichi Sankyo win U.S. approval for breast cancer drug
The Food and Drug Administration approved the drug for patients with advanced breast tumors whose cells bear a certain ...
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After Tough 2024, AstraZeneca/Daiichi Sankyo Push Enters Key Period
Even before the FDA's recent approval of Dato-DXd in breast cancer, analysts predicted sales of the antibody-drug conjugate ...