Outlook Therapeutics, Inc.
1 products tracked · names used in filings: Outlook Therapeutics, Inc.
Upcoming milestones
No upcoming milestones listed.
Recent milestones
ONS-5010: PDUFA target action date
Outlook Therapeutics, Inc. (OTLK); bevacizumab-vikg; BLA; status: set; "The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026."; filed 2026-06-16 · source
ONS-5010/LYTENAVA: PDUFA target action date (neovascular age-related macular degeneration (wet AMD))
Outlook Therapeutics, Inc. (OTLK); bevacizumab-vikg; BLA; status: set; "Exhibit 99.1 Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026"; filed 2026-06-16 · source
FDA approves biosimilar Lytenava (bevacizumab-vikg)
Outlook Therapeutics, Inc.; BLA761320; Biosimilar; vial · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇺🇸 | Lytenava bevacizumab-vikg | Approved | 2026-07-24 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.