FDA accepts Outlook Therapeutics' BLA resubmission for ONS-5010; PDUFA date Dec 31, 2025

Outlook Therapeutics, Inc.

FDA acknowledged receipt of BLA resubmission for ONS-5010 (bevacizumab-vikg) and assigned Class 1 review.
Class 1 review results in a two-month review period from resubmission date.
PDUFA goal date set for December 31, 2025.

item 8.01

Outlook Therapeutics, Inc. filing history →

Source: SEC EDGAR

accession 0001104659-25-111316

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