The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval for their ... the partners have secured a seventh nod for their original ADC, Enhertu. The U.S. regulator has cleared Enhertu ...
New approval brings the medicine to an earlier treatment setting and a broader patient population.
The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this ...
Following this approval for Enhertu in the U.S., AstraZeneca is due $175 million as a milestone payment to Daiichi Sankyo. Daiichi Sankyo recognizes Enhertu sales in the U.S. AstraZeneca reports ...
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. The FDA has approved ...
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...
(Alliance News) - AstraZeneca PLC and Daiichi Sankyo Co Ltd on Monday celebrated another approval of their cancer drug Enhertu. The Cambridge, England-based and Tokyo-based pharmaceutical ...
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. The antibody drug ...