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Bayer: completes FDA filing for prostate cancer drug

(CercleFinance.com) - Alongside its results, on Wednesday Bayer said that it has completed the submission of a new drug application to the US Food and Drug Administration for its investigational drug darolutamide for the treatment of prostate cancer.


The German drugmaker had previously been granted a so-called "fast track designation" by the FDA for darolutamide in men with non-metastatic castration-resistant prostate cancer.

The compound is being developed jointly with Finnish pharmaceutical company Orion.

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