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Darolutamide Approval Status

FDA Approved: No
Generic name: darolutamide
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Prostate Cancer

Darolutamide is an investigational, non-steroidal androgen receptor antagonist in development for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

Development Status and FDA Approval Process for darolutamide

DateArticle
Apr 29, 2019U.S. FDA Accepts New Drug Application and Grants Priority Review for Darolutamide
Feb 27, 2019Bayer Completes Rolling Submission of NDA for Investigational Drug Darolutamide for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)
Oct 24, 2018Phase III Trial of Darolutamide in Patients with Non-metastatic Castration-resistant Prostate Cancer Meets Primary Endpoint

Further information

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