FDA accepts resubmission of OTLK's BLA for ONS-5010; PDUFA date set for August 27, 2025

Outlook Therapeutics, Inc.

FDA acknowledged receipt of resubmission of BLA for ONS-5010 (bevacizumab-vikg).
FDA designated the BLA as a Class 2 review with a six-month review period.
PDUFA goal date for the BLA is August 27, 2025.

item 8.01

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company_name: Outlook Therapeutics, Inc.
filed_at: 2025-04-08T23:59:59+00:00
discovered_at: 2026-05-14T18:02:49.196862+00:00
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accession 0001558370-25-004606

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