The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with ...
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's ...
Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
AstraZeneca AZN announced that the FDA has approved its antibody-drug conjugate (ADC), datopotamab deruxtecan (or Dato-DXd), ...
The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU ...
Last week, the FDA accepted an application seeking approval of the ADC for EGFR-mutated non-small cell lung cancer. A regulatory decision in this indication is expected in the third quarter of ...
The US regulator has cleared TROP2-directed ADC datopotamab deruxtecan (Dato-DXd) under the Datroway trade name as a ...
DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival.
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FDA Expands Label of AZN's Enhertu for New Breast Cancer IndicationThe FDA approves AstraZeneca's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer in the United ...
Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatmentAlzheimer's disease progression does ...
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