EMA Authorised: Nubeqa (darolutamide) — Bayer AG

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Summary

The EMA authorised Nubeqa (darolutamide) for use in castration-resistant prostate cancer, expanding the drug's EU indication for Bayer AG as of 19 August 2025.

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Diseases / indications

• Castration-resistant Prostate Cancer
• Prostate Cancer

Drugs mentioned

• Nubeqa (darolutamide)

Snippet

Status: Authorised. Therapeutic area: Prostatic Neoplasms, Castration-Resistant. MAH: Bayer AG. Decision date: 19/08/2025