Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...

Enhertu is supplied in a single-dose vial containing 100mg of lyophilized powder for reconstitution and further dilution prior to IV infusion. Patients should be selected for treatment with ...

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

(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 ...

Just days after the FDA approved AstraZeneca and Daiichi Sankyo's Enhertu for a potentially lucrative new use, the regulatory has now cleared a diagnostic test that could help unlock the drug's ...

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 the US Food and Drug Administration (FDA) for an expanded indication of ...

AstraZeneca received Food and Drug Administration approval for enhertu, its breast cancer treatment developed in partnership with Japanese company Daiichi Sankyo. The Anglo-Swedish pharmaceutical ...

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 ...