Tag «Breakthrough Therapy Designations»

FDA approves new treatment for certain advanced or metastatic breast cancers

FDA approves new treatment for certain advanced or metastatic breast cancers The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy). …

FDA approves first treatment for a form of Batten disease, Brineura (cerliponase alfa)

FDA approves first treatment for a form of Batten disease 04/27/2017 The U.S. Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric patients 3 years of age and older …

FDA approves first drug Ingrezza (valbenazine) to treat tardive dyskinesia

Valbenazine Molecular FormulaC24H38N2O4 Average mass418.569 Da (2R,3R,11bR)-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl L-valinate (2R,3R,11bR)-9,10-dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H-benzo[a]quinolizin-2-yl L-valinate 1025504-45-3 cas L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester NBI-98854 Valbenazine ditosylate. RN: 1639208-54-0. UNII: 5SML1T733B, Molecular Formula, C24-H38-N2-O4.2C7-H8-O3-S, Molecular Weight, 762.9806 (2R,3R,11bR)-9,10-Dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H-benzo(a)quinolizin-2-yl L-valinate bis(4-methylbenzenesulfonate) and Valbenazine dihydrochloride 1639208-51-7 FDA approves first drug to treat tardive dyskinesia 04/11/2017 The U.S. Food and Drug Administration today approved Ingrezza (valbenazine) capsules to treat …

US FDA grants approval for Novartis’ Ilaris (canakinumab) to treat Periodic Fever Syndromes

Ribbon diagram of canakinumab (blue) bound to IL-1β (yellow) from PDBentry 5bvp[1] US FDA grants approval for Novartis’ Ilaris to treat Periodic Fever Syndromes Novartis has received the US Food and Drug Administration’s (FDA) approval for Ilaris (canakinumab) to treat rare Periodic Fever Syndrome conditions. 26 September 2016 Read at http://www.pharmaceutical-technology.com/news/newsus-fda-grants-approval-for-novartis-ilaris-to-treat-periodic-fever-syndromes-5014453?WT.mc_id=DN_News Novartis receives three FDA Breakthrough …