U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (for specialized target groups only)

Darolutamide was approved in the U.S. under the FDA Priority Review designation; approval granted three months ahead of target FDA action date / Approval based on Phase III ARAMIS trial evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT
Source: Bayer Company News - Category: Pharmaceuticals Source Type: news