The green light from the European Medicines Agency is the first backing in the EU for the medicine, following its approval in ...
The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this ...
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...
The Food and Drug Administration (FDA) last week granted the first approval for UK pharma major AstraZeneca’s Datroway ...
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 ...
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines for approval at its ...
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 Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, ...
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FDA expands Enhertu approval to include HER2-ultralow breast cancer patientsAstraZeneca and Daiichi Sankyo ’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from ...
The firms will evaluate two adjuvant treatment options, Datroway with rilvegostomig or rilvegostomig monotherapy, against standard-of-care treatment.
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