FDA says cannot approve Outlook Therapeutics ONS-5010 BLA in present form

Outlook Therapeutics (OTLK) announced that the FDA has issued a complete response letter to the ONS-5010/Lytenava biologics ...
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Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

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.