Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's ...
AstraZeneca AZN announced that the FDA has approved its antibody-drug conjugate (ADC), datopotamab deruxtecan (or Dato-DXd), ...
The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with ...
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 this year.
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...
AstraZeneca (AZ) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug ...
Following a world-first approval in Japan, AstraZeneca and Daiichi Sankyo’s second antibody-drug conjugate has crossed the ...
The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU ...
DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival.
The FDA approves AstraZeneca's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer in the United ...