Delcath Systems: Strong Position In Metastatic Uveal Melanoma, But Broader Growth Challenges Ahead
Delcath Systems markets Hepzato Kit for the treatment of uveal melanoma with unresectable hepatic metastases. Click here to read my analysis of DCTH stock.
verywellhealth1d
A New 'Missile' Drug Is Approved To Treat the Most Common Breast Cancer Type
The FDA approved Datroway to treat metastatic or unresectable HR+/HER2- breast cancer in people who have tried standard chemo ...
Targeted Oncology1d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
GlobalData on MSN2d
FDA grants breakthrough designation for Acrivon’s endometrial cancer assay
The US Food and Drug Administration (FDA) has granted breakthrough device designation for Acrivon Therapeutics’ ACR-368 ...
Targeted Oncology2d
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 ...
FDA approves new breast cancer treatment
The new drug is meant to treat specific types of advanced breast cancer which are resistant to hormone therapy.
oncnursingnews2d
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.
FierceBiotech3d
Roche's Enhertu companion diagnostic secures new FDA approval in HER2-ultralow breast cancer
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...
Pharm Exec3d
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow Breast Cancer Patients Eligible for Enhertu
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
FDA approval expands earlier use of Enhertu for metastatic breast cancer
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
oncnursingnews4d
Oncology Drugs Approved by the FDA in January 2025
January's FDA oncology approvals offer new treatment options for breast cancer, mantle cell lymphoma, and other malignancies.