XS003 (nilotinib) PDUFA Date (Xspray Pharma)
FDA PDUFA decision date for XS003 (nilotinib) is June 18, 2026. Developed by Xspray Pharma. Indication: Chronic myeloid leukemia (CML). Current status: Verifying.
Indication
Chronic myeloid leukemia (CML)
Notes
Novel formulation of nilotinib.
Regulatory details
- Company: Xspray Pharma
- Therapeutic area: Oncology
- Application type: NDA
- Review type: Standard
- PDUFA date: 2026-06-18
- Outcome: Pending