3 most recent filings and news items mentioning OTLK. Updated every 60 seconds.
RegulatoryJun 16, 2026Positive
Outlook Therapeutics announced FDA acceptance of its resubmitted Biologics License Application for ONS-5010/LYTENAVA (bevacizumab-vikg) as a treatment for wet AMD, with a PDUFA target action date of July 29, 2026. If approved, LYTENAVA would be the first FDA-approved ophthalmic f
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RegulatoryJun 1, 2026Positive
Outlook Therapeutics resubmitted its Biologics License Application for ONS-5010/LYTENAVA to the FDA after successfully appealing a Complete Response Letter, with a Class 1 review designation and expected decision within 60 days. If approved, the product would be the first FDA-app
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RegulatoryMay 26, 2026Positive
The FDA's Office of New Drugs determined that substantial evidence supports the effectiveness of ONS-5010/LYTENAVA for neovascular age-related macular degeneration following the formal dispute resolution process. Outlook plans to resubmit the biologics license application in June
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