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Bayer submits application in China for third indication of darolutamide

Written by | 13 Jan 2025

Bayer has filed an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for marketing authorization of the oral androgen receptor inhibitor… read more.

FDA accepts sNDA for Nubeqa (darolutamide) plus ADT to treat metastatic hormone-sensitive prostate cancer – Bayer

Written by | 29 Nov 2024

Bayer  announced that the  FDA has accepted the company’s supplemental new drug application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) in combination with androgen deprivation… read more.

Application submitted for third indication of darolutamide in the EU – Bayer

Written by | 19 Oct 2024

Bayer announced the submission of an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide. Bayer is seeking approval for the use… read more.

Darolutamide meets primary endpoint in phase III ARANOTE trial in men with metastatic hormone-sensitive prostate cancer – Bayer + Orion

Written by | 18 Jul 2024

The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS.( radiological progression-free survival). Darolutamide… read more.

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