Stelara (ustekinumab) PDUFA Date (Janssen Biotech)
FDA PDUFA decision date for Stelara (ustekinumab) is August 28, 2026. Developed by Janssen Biotech. Indication: Interleukin-12 Antagonist [EPC], Interleukin-23 Antagonist [EPC]. Current status: Approved.
Indication
Interleukin-12 Antagonist [EPC], Interleukin-23 Antagonist [EPC]
Regulatory details
- Company: Janssen Biotech
- Application type: sBLA
- Review type: Standard
- PDUFA date: 2026-08-28
- Outcome: Approved