PB016 Approval Pending
PB016 Approval Pending
U.S. License Holder:
Fresenius Kabi / Polpharma
Date of License:
aBLA accepted by FDA July-2026
Last Update:
September-15-2026
FDA-Approved IndicationsPB016 (vedolizumab) is not FDA-approved. An aBLA has been accepted by the FDA.
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