Benlysta (belimumab) PDUFA Date (Glaxosmithkline Llc)
FDA PDUFA decision date for Benlysta (belimumab) is August 21, 2026. Developed by Glaxosmithkline Llc. Indication: B Lymphocyte Stimulator-specific Inhibitor [EPC]. Current status: Approved.
Indication
B Lymphocyte Stimulator-specific Inhibitor [EPC]
Regulatory details
- Company: Glaxosmithkline Llc
- Application type: sBLA
- Review type: Standard
- PDUFA date: 2026-08-21
- Outcome: Approved