FDA, ENHERTU and Daiichi Sankyo

AZ, Daiichi's Enhertu nabs 7th FDA nod, including in 'HER2-ultralow' use, in breast cancer first
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's Enhertu as the first HER2-directed treatment for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapies.
FDA Approves AstraZeneca, Daiichi Sankyo's Enhertu For Certain Type Of Breast Cancer Patients
FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant efficacy in the DESTINY-Breast06 trial.
FDA Approves AstraZeneca, Daiichi Sankyo’s Enhertu for Unresectable or Metastatic Hormone Receptor-Positive, HER2-Low Breast Cancer
Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow metastatic breast cancer.
AstraZeneca, Daiichi’s drug cleared for wider use in breast cancer patients in US
Astra is due to pay Daiichi US$175 million in milestones after the US approval, the companies said. Enhertu is cleared in the US and European Union for some breast cancer patients whose cancer spread after receiving treatment, or whose disease returned after surgery.
AstraZeneca/Daiichi Sankyo’s Enhertu granted FDA approval in breast cancer
AstraZeneca (AZ) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration (FDA) to treat a new subset of breast cancer patients.
AstraZeneca & Daiichi Sankyo’s Enhertu Approved by FDA for Treatment of Metastatic Breast Cancer
New approval brings the medicine to an earlier treatment setting and a broader patient population.
AstraZeneca-Daiichi Sankyo Enhertu gets USFDA approval for HER2-ultralow metastatic breast cancer
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor
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. The Anglo-Swedish pharmaceutical company said Monday that the treatment's approval was based on results from a Phase III trial,
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,
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AstraZeneca, Daiichi Sankyo Continue ADC Rally With Enhertu Expansion
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...
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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 ...
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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 ...
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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 ...