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Bayer announces FDA acceptance of Nubeqa sNDA
The Fly

Bayer announces FDA acceptance of Nubeqa sNDA

Bayer (BAYRY) announced that the FDA has accepted the company’s supplemental new drug application, or sNDA, for the oral androgen receptor inhibitor, or ARi, Nubeqa in combination with androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer. Nubeqa is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer.

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