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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
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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