The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...

Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...

Robert F. Kennedy Jr. may soon be America's top pharmaceutical regulator. That is cause for concern in Seattle’s biotech ...

The agency approved the drug based on data from the DESTINY-Breast06 trial, which included patients who had tumors with very low HER2 expression.

New approval brings the medicine to an earlier treatment setting and a broader patient population.

AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...

The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...

FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant ...

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 ...

Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...

The Cambridge, England-based and Tokyo-based pharmaceutical companies said the US Food & Drug Administration approved Enhertu for the treatment of adult patients with unresectable or metastatic ...