Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review to darolutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The NDA and Priority Review status were based on data from the Phase III ARAMIS trial in men with nmCRPC. Darolutamide is an…
Bayer Receives FDA Approval for Jivi
The FDA approved Bayer’s Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. The initial recommended prophylactic regimen for Jivi is twice weekly with the ability to dose every five days and further individually adjust to less or more frequent…
Bayer And MD Anderson Cancer Center Collaborate
Bayer and The University of Texas MD Anderson Cancer Center signed a five-year collaboration agreement to accelerate the development of cancer treatments based on patient or tumor characteristics for which current therapies have not shown clinical efficacy. The collaboration will combine Bayer’s translational and clinical compounds with the translational and clinical expertise of the MD Anderson Cancer…