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 ...

“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 ...

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 ...

The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as ...

The FDA has approved Johnson & Johnson’s prostate cancer ... Pfizer/Astellas with Xtandi (enzalutamide), Bayer/Orion’s Nubeqa (darolutamide), and Takeda’s orteronel. Erleada is a successor ...

These launches are what Oelrich called “must-win battles” at Bayer as the Xarelto loss of exclusivity reaches “full swing” in ...