Category «FDA 2017»

FDA approves first biosimilar Herceptin (trastuzumab) for the treatment of certain breast and stomach cancers

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 of patients with breast or …

Copanlisib

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] Copanlisib is a selective pan-Class I …

Secnidazole, секнидазол , سيكنيدازول , 塞克硝唑 ,

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 , Approved September 2017 Secnidazole is …

FDA approves CAR-T cell therapy Yescarta (Axicabtagene ciloleucel) to treat adults with certain types of large B-cell lymphoma

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 B-cell lymphoma who have not …

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). …

Vaborbactam, Ваборбактам , فابورباكتام , 法硼巴坦 ,

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 of Action Beta lactamase inhibitors; Cell …

FDA approval brings first gene therapy to the United States

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. Food and Drug Administration issued …

FDA approves Mylotarg (gemtuzumab ozogamicin) for treatment of acute myeloid leukemia

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 aged 2 years and older …

FDA approves new antibacterial drug Vabomere (meropenem, vaborbactam)

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 certain types of resistance mechanisms …

FDA approves first U.S. treatment benznidazole for Chagas disease

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 disease. The U.S. Food and …