Wednesday, July 29, 2026
Approved
approved Note: Approved 2026-07-24 as LYTENAVA (ORIG BLA761320). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-02; 5d from the PDUFA date.
Drug Information
- Application Type
- BLA (Class 1 resubmission)
- Indication
- Wet age-related macular degeneration (wet AMD)
- Approved As
- ONS-5010/LYTENAVA (bevacizumab-vikg)
Filing Details
- Company
- Outlook Therapeutics, Inc. →
- Stock Ticker
- OTLK
- SEC CIK
- 0001649989
- Source
- SEC 8-K →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Explore Outlook Therapeutics, Inc.
View Outlook Therapeutics, Inc.'s full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-06-29. Report an issue