Outlook Therapeutics, Inc. (OTLK) Tuesday said it has resubmitted the Biologics License Application (BLA) for ONS-5010 for the treatment of wet age-related macular degeneration or wet AMD.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date or a date on which a decision from the regulator is expected, on August 27, 2025.
The BLA resubmission was based on data from NORSE EIGHT study as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA.
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