The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.
The firms will evaluate two adjuvant treatment options, Datroway with rilvegostomig or rilvegostomig monotherapy, against standard-of-care treatment.
The green light from the European Medicines Agency is the first backing in the EU for the medicine, following its approval in ...
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
AstraZeneca and Daiichi Sankyo ’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from ...
FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant ...
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's ...
Investors are awaiting the company's fourth-quarter results, scheduled for February 6, for an update on the China issue.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, ...
The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this ...
The Food and Drug Administration (FDA) last week granted the first approval for UK pharma major AstraZeneca’s Datroway ...
The Food and Drug Administration (FDA) has approved Datroway ® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human ...