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Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD

Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025 ISELIN, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic

articleOutlook Therapeutics, Inc.November 13, 20255/company/outlook-therapeutics-inc/news/outlook-therapeutics-announces-acceptance-biologics-133000245
Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD

About this update from Outlook Therapeutics, Inc.

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More updates from Outlook Therapeutics, Inc.

macular degenerationFDAVEGFbevacizumabPrescription Drug User Fee ActBiologics License ApplicationTherapeutics