U.S. FDA Accepts Supplemental New Drug Application for NUBEQA® (darolutamide) for the Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer [Yahoo! Finance]
ORION CORP NEW UNSP/ADR (ORINY)
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Source: Yahoo! Finance
therapy (ADT) significantly reduced the risk of progression or death in patients with metastatic hormone-sensitive prostate cancer (mHSPC) when compared to placebo plus ADT; no new safety signals were observed WHIPPANY, N.J., November 21, 2024 BUSINESS WIRE )--Bayer today announced that the U.S. Food and Drug Administration (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 therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). 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 (nmCRPC). "Bayer is dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease, and today's acceptance of our sNDA application for NUB
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- Bayer Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Indication for NUBEQA® (darolutamide) in Metastatic Hormone-Sensitive Prostate Cancer [Yahoo! Finance]Yahoo! Finance
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