U.S. License Holder:
Tanvex BioPharma, Inc.
Date of License:
aBLA accepted by FDA October-2021, CRL August-2022; Resubmitted July-2024, CRL January-2025
Last Update:
Jan-23-2025
FDA-Approved Indications
TX-05 (trastuzumab) is not FDA-approved. An aBLA has been accepted by the FDA.