Category «Priority review»

Teprotumumab-trbw

It’s only fair to share… Tepezza (teprotumumab-trbw) Company: Horizon Therapeutics plc Date of Approval: January 21, 2020 Treatment for: Thyroid Eye Disease Labels for BLA 761143 UNIIY64GQ0KC0A CAS number1036734-93-6 R-1507 / R1507 / RG-1507 / RG1507 / RO-4858696 / RO-4858696-000 / RO-4858696000 / RO4858696 / RO4858696-000 / RV-001 / RV001 Tepezza (teprotumumab-trbw) is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) for the treatment of active thyroid eye …

Brilliant blue G , ブリリアントブルーG ,

It’s only fair to share…   Brilliant blue G FDA 2019, 12/20/2019, TISSUEBLUE, New Drug Application (NDA): 209569 Company: DUTCH OPHTHALMIC, PRIORITY; Orphan OPQ recommends APPROVAL of NDA 209569 for commercialization of TissueBlue (Brilliant Blue G Ophthalmic Solution), 0.025% Neuroprotectant sodium;3-[[4-[[4-(4-ethoxyanilino)phenyl]-[4-[ethyl-[(3-sulfonatophenyl)methyl]azaniumylidene]-2-methylcyclohexa-2,5-dien-1-ylidene]methyl]-N-ethyl-3-methylanilino]methyl]benzenesulfonate Formula C47H48N3O7S2. Na CAS 6104-58-1 Mol weight 854.0197 ブリリアントブルーG, C.I. Acid Blue 90 UNII-M1ZRX790SI M1ZRX790SI 6104-58-1 Brilliant Blue G Derma …

Avapritinib, アバプリチニブ , авапритиниб , أفابريتينيب ,

It’s only fair to share… Avapritinib BLU-285, BLU285 Antineoplastic, Tyrosine kinase inhibitor アバプリチニブ авапритиниб [Russian] [INN] أفابريتينيب [Arabic] [INN] (1S)-1-(4-fluorophenyl)-1-[2-[4-[6-(1-methylpyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl]piperazin-1-yl]pyrimidin-5-yl]ethanamine (1S)-1-(4-Fluorophenyl)-1-(2-{4-[6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl]-1-piperazinyl}-5-pyrimidinyl)ethanamine 10613 1703793-34-3 [RN] 513P80B4YJ 5-Pyrimidinemethanamine, α-(4-fluorophenyl)-α-methyl-2-[4-[6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl]-1-piperazinyl]-, (αS)- (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazin-1-yl)pyrimidin-5-yl)ethan-1-amine (αS)-(4-fluorophenyl)-α-methyl-2-[4-[6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl]-1-piperazinyl]-5-pyrimidinemethanamine Formula C26H27FN10 CAS 1703793-34-3 Mol weight 498.558 No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date* 1. Ayvakit avapritinib 1/9/2020 To treat adults with unresectable or metastatic …

FDA approves first treatment Givlaari (givosiran) for inherited rare disease

It’s only fair to share… Today, the U.S. Food and Drug Administration granted approval to Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme (which helps bind oxygen in the blood). “This buildup …

FDA approves first treatment Dupixent (Dupilumab) for chronic rhinosinusitis with nasal polyps

It’s only fair to share… The U.S. Food and Drug Administration today approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). This is the first treatment approved for inadequately controlled chronic rhinosinusis with nasal polyps. …

FDA approves first treatment Soliris (eculizumab) for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

It’s only fair to share… The U.S. Food and Drug Administration today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal …

FDA approves third oncology drug Rozlytrek (entrectinib) that targets a key genetic driver of cancer, rather than a specific type of tumor

It’s only fair to share… FDA approves third oncology drug Rozlytrek (entrectinib) that targets a key genetic driver of cancer, rather than a specific type of tumor  FDA also approves drug for second indication in a type of lung cancer The U.S. Food and Drug Administration today granted accelerated approval to Rozlytrek (entrectinib), a treatment for …

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 …

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 …