It’s only fair to share… FDA approves first biosimilar for the treatment of certain breast and stomach cancers Ogivri, a biosimilar to the cancer drug Herceptin, is approved for HER2+ breast cancer and metastatic stomach cancers The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment …
Category «FDA 2017»
Copanlisib
It’s only fair to share… Copanlisib, BAY 80-6946, BAY 84-1236 Molecular FormulaC23H28N8O4 Average mass480.520 Da Cas 1032568-63-0 [RN] 1402152-26-4 MONO HCL UNII-WI6V529FZ9 FDA Approved September 2017 2-Amino-N-{7-methoxy-8-[3-(4-morpholinyl)propoxy]-2,3-dihydroimidazo[1,2-c]quinazolin-5-yl}-5-pyrimidinecarboxamide 5-Pyrimidinecarboxamide, 2-amino-N-[2,3-dihydro-7-methoxy-8-[3-(4-morpholinyl)propoxy]imidazo[1,2-c]quinazolin-5-yl]- orphan drug status for follicular lymphoma Copanlisib (BAY 80-6946), developed by Bayer, is a selective Class I phosphoinositide 3-kinase inhibitor[1] which has shown promise in Phase I/II clinical trials for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia.[2] …
Secnidazole, секнидазол , سيكنيدازول , 塞克硝唑 ,
It’s only fair to share… Secnidazole Molecular FormulaC7H11N3O3 Average mass185.180 Da 1-(2-Methyl-5-nitroimidazol-1-yl)-2-propanol 1H-Imidazole-1-ethanol, α,2-dimethyl-5-nitro- [ACD/Index Name] 222-134-0 [EINECS] 3366-95-8 [RN] a,2-Dimethyl-5-nitro-1H-imidazole-1-ethanol UNII:R3459K699K секнидазол[Russian][INN] سيكنيدازول[Arabic][INN] 塞克硝唑[Chinese][INN] RP-14539, PM-185184, Flagentyl Company: Symbiomix Therapeutics Approval Status: Approved FDA September 2017 Specific Treatments: bacterial vaginosis Therapeutic Areas Obstetrics/Gynecology (Women’s Health) Infections and Infectious Diseases Solosec (secnidazole) ; Symbiomix Therapeutics; For the treatment of bacterial vaginosis , …
FDA approves CAR-T cell therapy Yescarta (Axicabtagene ciloleucel) to treat adults with certain types of large B-cell lymphoma
It’s only fair to share… FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma Yescarta is the second gene therapy product approval in the U.S. The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large …
FDA approves new treatment for certain advanced or metastatic breast cancers
It’s only fair to share… 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 …
Vaborbactam, Ваборбактам , فابورباكتام , 法硼巴坦 ,
It’s only fair to share… Vaborbactam RN: 1360457-46-0 UNII: 1C75676F8V Molecular Formula. C12-H16-B-N-O5-S Molecular Weight. 297.1374 1,2-Oxaborinane-6-acetic acid, 2-hydroxy-3-((2-(2-thienyl)acetyl)amino)-, (3R,6S)- B1([C@H](CC[C@H](O1)CC(=O)O)NC(=O)Cc2cccs2)O RPX7009 A beta-lactamase inhibitor. Treatment of Bacterial Infection {(3R,6S)-2-Hydroxy-3-[(2-thienylacetyl)amino]-1,2-oxaborinan-6-yl}acetic acid 2-[(3R,6S)-2-hydroxy-3-[(2-thiophen-2-ylacetyl)amino]oxaborinan-6-yl]acetic acid 1,2-Oxaborinane-6-acetic acid, 2-hydroxy-3-[[2-(2-thienyl)acetyl]amino]-, (3R,6S)- Ваборбактам [Russian] فابورباكتام [Arabic] 法硼巴坦 [Chinese] Originator Rempex Pharmaceuticals Developer The Medicines Company; US Department of Health and Human Services Class Antibacterials; Pyrrolidines; Small molecules; Thienamycins Mechanism …
FDA approval brings first gene therapy to the United States
It’s only fair to share… FDA approval brings first gene therapy to the United States 08/30/2017 The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases The U.S. …
FDA approves Mylotarg (gemtuzumab ozogamicin) for treatment of acute myeloid leukemia
It’s only fair to share… FDA approves Mylotarg for treatment of acute myeloid leukemia 09/01/2017 The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients …
FDA approves new antibacterial drug Vabomere (meropenem, vaborbactam)
It’s only fair to share… Meropenem Beta-lactamase inhibitor vaborbactam FDA approves new antibacterial drug 08/29/2017 The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits …
FDA approves first U.S. treatment benznidazole for Chagas disease
It’s only fair to share… FDA approves first U.S. treatment for Chagas disease 08/29/2017 The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas …