News
The approval was based on data from the phase 2/3 OSPREY and phase 3 CONDOR trials that evaluated the diagnostic performance and safety of Pylarify injection.
News
The approval was based on efficacy and safety data from 2 prospective clinical trials.
News, Safety Alerts and Recalls
The FDA has concluded that the use of entacapone to treat Parkinson disease (PD) does not increase the risk of developing prostate cancer.
Drugs in the Pipeline
The sNDA is supported by data from the phase 3 ARASENS trial, which included1306 patients with mHSPC.
News
The FDA has approved Nubeqa (darolutamide; Bayer), an androgen receptor inhibitor, for the treatment of patients with nonmetastatic castration resistant prostate cancer (nmCRPC).
News
Pluvicto is a radioligand therapeutic agent containing the active moiety, lutetium-177, which binds to PSMA, a transmembrane protein that is expressed in prostate cancer.
Drugs in the Pipeline
Following a planned interim analysis, the decision to halt the trial was made after a review of data by an independent Data Monitoring Committee.
News
Camcevi is a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, a gonadotropin-releasing hormone agonist.
News
Entadfi is a fixed-dose combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
News
Orgovyx is an oral nonpeptide gonadotropin-releasing hormone (GnRH) receptor antagonist.
