The US Food and Drug Administration (FDA) today approved an oral form of androgen deprivation therapy (ADT) known asrelugolix(Orgovyx) for the treatment of adult patients with advancedprostate cancer. Relugolix is an oral gonadotropin-releasing hormone antagonist. The new pill form may mean fewer...
a new drug to treat low sexual desire in premenopausal women, the first FDA-approved drug specifically for the treatment of adult women with postpartum depression, and a new therapy for an oral testosterone capsule to treat men with
Previously approved forms of testosterone replacement therapy include oral and buccal tablets, subcutaneous pellets, transdermal patches, injections, a topical solution applied to the underarm, and topical gels applied to the upper body. Dr. Dobs served as a principal investigator for the Fortesta ge...
2014年上半年美国FDA批准药物简介
FDA approvals Tlando, an oral testosterone replacement. The FDAhas grantedfinal approval for Tlando (testosterone undecanoate), a treatment for testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. Developed by ...
(testosterone ) 新鼻 内胶剂 Trimel Pharmaceuticals 男性生殖功能低下 2014/06/06 Jublia 依非康唑(efinaconazole ) 新分子实体 Valeant 趾甲真菌病 2014/06/06 Eloctate 重组抗血友病球蛋 白 Fc 融合蛋 白 新重组白 Biogen Idec 血友病 A 2014/06/06 Bunavail 丁丙诺啡和纳洛酮 新颊膜剂型 BioDelivery ...
Approved Uses CRENESSITY (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic cong...
Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Food and Drug Administration announced Friday. As opposed to currently approved hormone therapies that are injected or placed as implants under the ...
PSAand/orradiographicscanswhilemaintainingcastratelevelsoftestosterone. Patientswererandomized2:1toreceiveeitherMDV3100orplacebo,asshownin Figure2.Treatmentcontinueduntilunacceptabletoxicity,diseaseprogressionas definedintheprotocol,death,orwithdrawal.AnindependentIDMCwasformedprior tothestudyinitiationtomonitorsafetyduring...
eligible for inclusion in the study, patients must be 18 years of age or older with a histological, pathological, or cytological confirmation for mCRCP, show PSMA on a PET scan, have adequate organ function, an ECOG performance status of 0 or 1, and proper castrate circulating testosterone ...