Other Events · Jun 16, 2026

FDA acknowledges resubmitted BLA for ONS-5010, sets PDUFA goal date of July 29, 2026

OTLKOutlook Therapeutics, Inc.

On June 16, 2026, the FDA acknowledged receipt of the resubmitted Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg). The FDA designated the BLA as a Class 1 review, establishing a 60-day review period and setting a PDUFA goal date of July 29, 2026. Outlook Therapeutics is a biopharmaceutical company developing therapies for ocular diseases.