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

Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...

The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...

The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...

The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...

Fact checked by Nick Blackmer The Food and Drug Administration (FDA) recently approved a new targeted chemotherapy drug for ...

Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...

Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's ...

The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...

Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...

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