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Outlook Therapeutics says FDA accepts resubmitted Lytentava BLA for wet AMD review

PUBT·06/16/2026 12:03:54
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Outlook Therapeutics says FDA accepts resubmitted Lytentava BLA for wet AMD review
  • Outlook Therapeutics won FDA acceptance of its resubmitted BLA for ONS-5010/LYTENAVA (bevacizumab-vikg) to treat wet AMD.
  • FDA set a Class 1 review with a PDUFA target action date of July 29, 2026.
  • Decision could clear the first FDA-approved ophthalmic bevacizumab formulation, supporting standardized manufacturing, labeling, pharmacovigilance.


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 GlobeNewswire (Ref. ID: 202606160802PRIMZONEFULLFEED9747297) on June 16, 2026, and is solely responsible for the information contained therein.