Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA
Outlook Therapeutics submitted a formal dispute resolution request to the FDA following a Complete Response Letter on its Biologics License Application for ONS-5010/LYTENAVA™, an ophthalmic bevacizumab formulation for wet age-related macular degeneration (AMD). The FDA accepted the request and scheduled a meeting. The company emphasizes sufficient …