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

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

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

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

HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The approval by the US Food and ...

Oli Welsh is senior editor, U.K., providing news, analysis, and criticism of film, TV, and games. He has been covering the business & culture of video games for two decades. After many months, if ...

WILMINGTON, Del., January 17, 2025--(BUSINESS WIRE)--DATROWAY ® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone ...

First approval in the U.S. for Daiichi Sankyo and AstraZeneca’s DATROWAY based on TROPION-Breast01 results showing 37% reduction in the risk of disease progression or death versus chemotherapy ...

In the trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: ...

DATROWAY (6 mg/kg) is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who ...

DATROWAY ® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or ...