Targeted Oncology3d
The Targeted Pulse: The Latest FDA Actions Across Cancer Types and Exploring the Efficiency of Remote Pharmacists in Community Oncology
The FDA makes furthering moves in SCLC, ovarian, and breast cancers, and the value of remote clinical pharmacists is explored in community oncology.
Targeted Oncology15d
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
oncnursingnews15d
T-DXd Companion Diagnostic in HER2-Ultralow Metastatic Breast Cancer Gains FDA Approval
The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer ...
Pharm Exec16d
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow Breast Cancer Patients Eligible for Enhertu
Roche has received FDA approval for a label expansion of its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which identifies patients with HR–positive, HER2-ultralow metastatic ...
BioSpace18d
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
Basel, 31 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY® anti-HER2/neu (4B5) Rabbit ...