The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer are eligible for T-DXd treatment.

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

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

During a Case-Based Roundtable event, Laura Huppert, MD, discussed data and considerations around using T-DXd in breast ...

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

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

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

Roche has announced that the FDA has expanded the approval of its PATHWAY® HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to identify HE ...

Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY ...

Q3 2024 Management View Revenue for Q3 FY2024 increased 16.6% year-on-year to ¥1,367.6 billion, driven by growth in oncology and international markets. Core operating profit rose 33% to ¥229 billion.

Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...

The tissue-based test is approved to identify a new classification in HER2 expression designated as HER2-ultralow.