Yesintek (ustekinumab-kfce) PDUFA Date (Biocon Biologics Inc)
FDA PDUFA decision date for Yesintek (ustekinumab-kfce) is August 14, 2026. Developed by Biocon Biologics Inc. Indication: Interleukin-12 Antagonist [EPC], Interleukin-23 Antagonist [EPC]. Current status: Approved.
Indication
Interleukin-12 Antagonist [EPC], Interleukin-23 Antagonist [EPC]
Regulatory details
- Company: Biocon Biologics Inc
- Application type: sBLA
- Review type: Standard
- PDUFA date: 2026-08-14
- Outcome: Approved