Outlook Therapeutics Completes Federal Dispute Resolution (FDR) Meeting with FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
Outlook Therapeutics completed a Federal Dispute Resolution (FDR) meeting with the FDA Office of New Drugs regarding the regulatory pathway for ONS-5010/LYTENAVA. The meeting follows the Complete Response Letter received in December 2025 for the treatment of neovascular age-related macular degeneration. The company expects to receive formal feedback from the Agency in May 2026 and remains committed to establishing a clear path toward potential U.S.
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