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Bayer Announces the FDA Accepted the NDA and Granted Priority Review to Darolutamide for Treatment of Non-Metastatic Castration-resistant Prostate Cancer

15:33 EDT 29 Apr 2019 | Speciality Pharma Journal

WHIPPANY, N.J., April 29, 2019 /PRNewswire/ — Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review to darolutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The NDA and Priority Review status were based on data from the Phase III ARAMIS trial …

Original Article: Bayer Announces the FDA Accepted the NDA and Granted Priority Review to Darolutamide for Treatment of Non-Metastatic Castration-resistant Prostate Cancer

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