FDA Sets December 31 PDUFA Date for Outlook Therapeutics’ ONS-5010 BLA Review
Outlook Therapeutics announced that the FDA has received its resubmitted Biologics License Application for ONS-5010 (bevacizumab-vikg). The FDA classified it as a Class 1 review with a two-month review period and set a PDUFA goal date of December 31, 2025, for the decision.
Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its resubmitted Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg). The FDA classified the submission as a Class 1 review, initiating a two-month review period. The agency set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025, for its decision on the application. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Outlook Therapeutics Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001104659-25-111316), on November 13, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
