AstraZeneca AZN announced that the FDA has accepted the supplemental new drug application (sNDA), seeking approval for the ...

The antibody-drug conjugate will be reviewed for the potential treatment of previously treated, unresectable or metastatic ...

AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has ...

A significant minority of patients with brain metastases may avoid radiotherapy, but they need to be carefully selected.

The FDA expects to issue a decision in the first quarter of 2025, and if the agency grants approval, it will expand the biomarker-eligible population for the drug.

(IN BRIEF) AstraZeneca and Daiichi Sankyo announced that their drug Enhertu (trastuzumab deruxtecan) has been granted Priority Review by the US FDA for treating patients with unresectable or ...

AstraZeneca and Daiichi Sankyo announced that their drug Enhertu (trastuzumab deruxtecan) has been granted Priority Review by the US FDA for trea ...

Over the next three months, the agency could approve a rival to a fast-selling Pfizer heart drug, a much-debated lung cancer medicine and an addition to Vertex's dominant cystic fibrosis business.

The sBLA is supported by results from the phase IIIDESTINY-Breast06 trial (NCT04494425), which showed that patients with HER2 ...

The FDA grants priority review to AZN's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer. A ...

(Alliance News) - AstraZeneca PLC and Daiichi Sankyo Co Ltd on Tuesday said their cancer drug Enhertu received a priority review by the Food & Drug Administration in the US for some forms of breast ...