Henlius e Organon anunciam aprovação do POHERDY® (pertuzumabe-dpzb) pela FDA, o primeiro biossimilar de PERJETA (pertuzumabe) nos EUA

A Shanghai Henlius Biotech, Inc. (2696.HK) e a Organon (NYSE: OGN) anunciaram hoje que a Food and Drug Administration (FDA) ...
The Manila Times

Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US

Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® ...
Managed Healthcare Executive

FDA approves Poherdy, first biosimilar of Perjeta, to treat HER-positive breast cancer

Poherdy is the first FDA-approved interchangeable biosimilar to Perjeta for HER2-positive breast cancer, potentially expanding access and reducing costs. Approved for use in combination with ...
CURE

FDA Approves First Interchangeable Biosimilar to Perjeta in HER2+ Breast Cancer

The U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb) as the first interchangeable biosimilar to ...
Frontiers

Anti-HER2/neu TCR-T Cells in Action: Linking Transcriptional Signatures, Secretomics, and In Vivo Tumor Suppression

1 Laboratory of Molecular Immunology, Research Institute of Fundamental and Clinical Immunology., Novosibirsk, Russia 2 Federal State Autonomous Educational Institution of Higher Education, I.M.
Nasdaq

Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation

STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, ...
Oncology Nurse Advisor

Study Reveals Low Rate of HER2 Positivity Across Solid Tumors

The highest rates of HER2 positivity were observed in bladder cancer, uterine serous carcinoma, and esophagogastric junction cancer. New research suggests the incidence of HER2 positivity is low ...
Targeted Oncology

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 prior HER2-low indication. The FDA has expanded the label for the PATHWAY anti ...
oncnursingnews

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 are eligible for T-DXd treatment. The FDA has approved a label expansion ...
The American Journal of Managed Care

FDA Approves First HER2-Ultralow Companion Diagnostic, Expanding Treatment Eligibility

FDA approval of PATHWAY HER2 (4B5) test expands diagnostic capabilities for HER2-ultralow metastatic breast cancer, enabling targeted treatment with trastuzumab deruxtecan. HER2-ultralow ...
360dx

FDA Approves Roche Antibody Test as CDx for Enhertu in HER2-Ultralow Breast Cancer Patients

NEW YORK – Roche announced on Friday that its Pathway Anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody has received a label expansion from the US Food and Drug Administration as a companion ...