TX-05 Approval Pending
TX-05 Approval Pending
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:
Sep-30-2025
FDA-Approved IndicationsTX-05 (trastuzumab) is not FDA-approved. An aBLA has been accepted by the FDA.
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