men’s health

Erleada gains first-mover advantage in CRPC

The 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics, predicted approval and market entry of Johnson & Johnson’s Erleada (apalutamide), the first FDA-approved treatment for non-metastatic castration-resistant prostate cancer (CRPC).1,2 This approval came two months ahead of its April 2018 PDUFA date and only four months after its […]

FDA efficacy recommendations vary for hypogonadotropic hypogonadism drugs

New draft industry guidance from the U.S. Food and Drug Administration (FDA) underscores the importance of randomized, double-blind, placebo-controlled trials to establish the efficacy of drugs to treat male hypogonadotropic hypogonadism when it is caused by obesity or another acquired condition. The draft guidance also asserts the potential importance of patient-reported outcome (PRO) instruments to […]