A potential FDA approval of the sNDA will expand the indication for Nubeqa in patients with mHSPC to include Nubeqa both with and without chemotherapy. BAYRY is also evaluating darolutamide across ...

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 ...

“If approved, this would expand the indication ... "Bayer expands indications for Nubeqa with new drug application" was originally created and published by Clinical Trials Arena, a GlobalData ...

which developed Nubeqa in collaboration with Finland's Orion. The drug is already approved to treat non-metastatic castration-resistant prostate cancer (CRPC), but expansion into hormone-sensitive ...

Researchers will use a lipidomic biomarker test to select patients with a poor prognosis who may benefit from an investigational combination therapy.

Bayer seeks China NMPA marketing authorization for ARi darolutamide in combo with ADT in patients with metastatic hormone-sensitive prostate cancer: Berlin Wednesday, January 8, 2 ...

Finnish drugmaker Orion wants to boost sales in the United States on the back of the success of its prostate cancer drug Nubeqa, which it is developing jointly with German partner Bayer , Orion's ...

Besides label expansions for in-market products such as prostate cancer drug Nubeqa and kidney disease ... In the U.S., following an FDA approval in November and an official launch Dec. 11 ...