Category «FDA 2019»

FDA approves new treatment Victoza (liraglutide) for pediatric patients with type 2 diabetes

It’s only fair to share…     The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. …

FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia

It’s only fair to share… The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The FDA initially approved Zerbaxa in 2014 to treat complicated intra-abdominal infections …

Onasemnogene abeparvovec オナセムノジーンアベパルボベック

It’s only fair to share…   Onasemnogene abeparvovec オナセムノジーンアベパルボベック DNA (synthetic adeno-associated virus 9 vector scAAV9.CB.hSMN human survivor motor neuron protein-specifying) Zolgensma FDA 2019/5/24 APPROVED CAS: 1922968-73-7 AVXS-101 Spinal muscular atrophy treatment Treatment of Spinal Muscular Atrophy (SMA) Type 1 Gene therapy product Onasemnogene abeparvovec, sold under the trade name Zolgensma, is a gene therapy medication used to treat spinal muscular atrophy (SMA). …

FDA approves first PI3K inhibitor Piqray (alpelisib) for breast cancer

It’s only fair to share… FDA approves first PI3K inhibitor for breast cancer syn https://newdrugapprovals.org/2018/06/25/alpelisib-byl-719/ Today, the U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced …

FDA approves first treatment Ruzurgi (amifampridine) for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

It’s only fair to share… FDA approves first treatment Ruzurgi (amifampridine)  for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA …

Erdafitinib, エルダフィチニブ ,Эрдафитиниб , إيردافيتينيب , 厄达替尼 ,

It’s only fair to share… Erdafitinib エルダフィチニブ JNJ-42756493 CAS 1346242-81-6 MF, C25H30N6O2, MW 446.54 UNII-890E37NHMV 890E37NHMV 2019/4/12, FDA APPROVED, BALVERSA (Janssen Products LP) Balversa Эрдафитиниб [Russian] [INN] إيردافيتينيب [Arabic] [INN] 厄达替尼 [Chinese] [INN] N‘-(3,5-dimethoxyphenyl)-N‘-[3-(1-methylpyrazol-4-yl)quinoxalin-6-yl]-N-propan-2-ylethane-1,2-diamine 1,2-Ethanediamine, N1-(3,5-dimethoxyphenyl)-N2-(1-methylethyl)-N1-[3-(1-methyl-1H-pyrazol-4-yl)-6-quinoxalinyl]- [ACD/Index Name] 10147 1346242-81-6 [RN] 890E37NHMV N-(3,5-dimethoxyphenyl)-N’-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine 5SF MFCD28502040 N’-(3,5-dimethoxyphenyl)-N’-[3-(1-methylpyrazol-4-yl)quinoxalin-6-yl]-N-propan-2-ylethane-1,2-diamine N1-(3,5-dimethoxyphenyl)-N2-(1-methylethyl)-N1-[3-(1-methyl-1H-pyrazol-4-yl)-6-quinoxalinyl]-1,2-ethanediamine Erdafitinib is an orally bioavailable, pan fibroblast growth factor receptor (FGFR) inhibitor with potential antineoplastic activity. Upon oral administration, erdafitinib binds …

First FDA-approved vaccine Dengvaxia for the prevention of dengue disease in endemic regions

It’s only fair to share… First FDA-approved vaccine for the prevention of dengue disease in endemic regions May 01, 2019 The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people …

FDA approves first treatment Benlysta (belimumab) for pediatric patients with lupus

It’s only fair to share…   The U.S. Food and Drug Administration today approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) – often referred to as simply “lupus” – a serious chronic disease that causes inflammation and damage to various body tissues and organs. This is the first …

Solriamfetol hydrochloride, ソルリアムフェトル塩酸塩 , солриамфетол , سولريامفيتول , 索安非托 ,

It’s only fair to share… Solriamfetol hydrochloride FDA APPROVED 2019/3/20, Sunosi ソルリアムフェトル塩酸塩; R228060, R 228060 Formula C10H14N2O2. HCl CAS 178429-65-7 HCL Mol weight 230.6913 (2R)-2-Amino-3-phenylpropyl carbamate (2R)-2-Amino-3-phenylpropylcarbamat 10117 178429-62-4 [RN] FREE FORM Benzenepropanol, β-amino-, carbamate (ester), (βR)- [ солриамфетол [Russian] [INN] سولريامفيتول [Arabic] [INN] 索安非托 [Chinese] [INN] JZP-110 Originator SK Holdings Developer Jazz Pharmaceuticals plc; SK biopharmaceuticals Class Carbamates; Sleep disorder therapies; Small molecules Mechanism of Action Adrenergic uptake inhibitors; Dopamine uptake …

Certolizumab pegol, セルトリズマブペゴル (遺伝子組換え)

It’s only fair to share… >Amino acid sequence of the light chain DIQMTQSPSSLSASVGDRVTITCKASQNVGTNVAWYQQKPGKAPKALIYSASFLYSGVPY RFSGSGSGTDFTLTISSLQPEDFATYYCQQYNIYPLTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC >Amino acid sequence of the heavy chain EVQLVESGGGLVQPGGSLRLSCAASGYVFTDYGMNWVRQAPGKGLEWMGWINTYIGEPIY ADSVKGRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCARGYRSYAMDYWGQGTLVTVSSAS TKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGL YSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCAA Certolizumab pegol CAS: 428863-50-7 セルトリズマブペゴル (遺伝子組換え) CDP 870 / CDP-870 / CDP870 / PHA-738144 Formula C2115H3252N556O673S16 Cas 428863-50-7 Mol weight 47748.8128   Reducing signs and symptoms of Crohn’s disease and treatment of moderately to severely …