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 ...
New approval brings the medicine to an earlier treatment setting and a broader patient population.
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 ...
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 ...
(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 ...
(AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive ...
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 ...