Darolutamide: First Approval

Author:

Markham Anthony,Duggan Sean

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical)

Reference21 articles.

1. Fizazi K, Smith MR, Tombal B. Clinical development of darolutamide: a novel androgen receptor antagonist for the treatment of prostate cancer. Clin Genitourin Cancer. 2018;16(5):332–40.

2. US Food & Drug Administration. FDA approves darolutamide for non-metastatic castration-resistant prostate cancer [media release]. 1 Aug 2019. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-non-metastatic-castration-resistant-prostate-cancer .

3. Bayer. Bayer submits European marketing authorization application for darolutamide [media release]. 8 Mar 2019. http://www.bayer.com .

4. Orion. Darolutamide submitted for marketing authorization in Japan [media release]. 5 Mar 2019. http://www.orion.fi .

5. Bayer HealthCare Pharmaceuticals Inc. Nubeqa™ (darolutamide): US prescribing information. 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212099Orig1s000lbl.pdf . Accessed 19 Aug 2019.

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