darolutamide (Nubeqa): FDA status

Approved Approved Jun 3, 2025. Indication: metastatic hormone sensitive prostate cancer. Company: Bayer.

Regulatory history

• Jun 3, 2025: Label expanded. FDA approved darolutamide for metastatic castration sensitive prostate cancer allowing use with hormone therapy alone without chemotherapy. fda.gov
• Nov 21, 2024: FDA accepted for review. FDA accepted supplemental NDA for darolutamide with ADT for metastatic hormone sensitive prostate cancer. Pharmacy Times

All products in the FDA Tracker