Tokai Pharmaceuticals has gained FDA fast track designation for galeterone (TOK-001) for the potential treatment of metastatic castration-resistant prostate cancer (CRPC). Galeterone disrupts androgen receptor (AR) signaling, the key ...
Tags: galeterone, TOK-001, castration-resistant prostate cancer, CRPC
The US Patent and Trademark Office (USPTO) has granted a patent for the use of Aeterna Zentaris' oral ghrelin agonist, AEZS-130 (EP1572) as a diagnostic test for adult growth hormone deficiency (AGHD). AEZS-130, which has been granted ...
Tags: AEZS-130, growth hormone deficiency, AGHD
The US Food and Drug Administration (FDA) has granted fast track designation for Idenix Pharmaceuticals' IDX719 to treat chronic hepatitis C infection (HCV). IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent ...
Tags: IDX719, HCV, chronic hepatitis C infection
The US Food and Drug Administration (FDA) has granted fast track designation to Alvine Pharmaceuticals' ALV003 for the potential treatment of celiac disease. Alvine is at present conducting Phase 2 trials with ALV003, an orally ...
Tags: ALV003, treatment of celiac disease, orally administered mixture
The US FDA has granted fast track status to Soligenix's SGX203 for the treatment of pediatric Crohn's disease. SGX203 contains an active corticosteroid, beclomethasone 17,21-dipropionate (BDP), that targets local inflamed tissue. ...
XBiotech has received FDA fast track designation for its anti-cachexia drug Xilonix, a first-in-class True Human antibody. Xilonix blocks an inflammatory substance (IL-1a) produced by the body in response to tumor growth, which plays a ...
The FDA has granted fast track designation for Achillion Pharmaceuticals' ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV). ACH-3102 is a pan-genotypic second-generation NS5A inhibitor ...
Tags: FDA Fast Track Designation, chronic hepatitis C, pharmaceutical product
EpiCept has received fast track designation for AmiKet (amitriptyline 4%, ketamine 2% cream) from the US Food and Drug Administration (FDA). AmiKet is indicated for the treatment of neuropathic pain associated with ...
Tags: FDA, fast track designation, treatment of neuropathic pain