Bayer: submits prostate cancer drug for European approval

(CercleFinance.com) - Germany's Bayer has submitted a marketing application for darolutamide for the treatment of prostate cancer to European drugs authorities, it said on Friday.


Bayer said it has submitted a marketing authorisation application to the European Medicines Agency (EMA) for the compound it has developed with Finland's Orion for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

Bayer recently completed the submission of a filing to the United States Food and Drug Administration (FDA) and submitted an application to the Ministry of Health, Labor and Welfare (MHLW) in Japan, it said.

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