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 ...

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

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

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, ...

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

Sanofi SNY and Roche RHHBY announced their fourth-quarter and full-year 2024 results. Novo Nordisk’s NVO novel obesity ...

AstraZeneca on Thursday warned that it could be fined millions of dollars in importation tax fines as Chinese authorities ...

The FDA approved Datroway to treat metastatic or unresectable HR+/HER2- breast cancer in people who have tried standard chemo ...

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

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