Bayer BAYRY announced that the FDA has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide). The ...

Bayer BAYRY announced that the FDA has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide). The sNDA is seeking label expansion of Nubeqa in combination with androgen ...

Bayer and Orion’s prostate cancer drug Nubeqa (darolutamide) is gaining steam in its battle against rivals from J&J and Pfizer/Astellas as Japan becomes the latest country to approve the drug.

The US regulator has approved Nubeqa (darolutamide) in combination with docetaxel chemotherapy for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), adding to its earlier ...

The Food and Drug Administration (FDA) accepted a supplemental new drug application for Nubeqa (darolutamide) plus androgen deprivation therapy to treat metastatic hormone-sensitive prostate cancer.

Dubbed Nubeqa but known generically as darolutamide, the treatment comes in combination with androgen deprivation therapy (ADT). The sNDA application is based on positive results from the company ...