#fda 2016

ヌシネルセンナトリウム Nusinersen Sodium C234H323N61Na17O128P17S17 : 7500.89 [1258984-36-9 , ヌシネルセン] Nusinersen sodium C234H323N61O128P17S17.17Na, 7500.8854 UNII 4CHB7QQU1Q ISIS 396443 Nusinersen sodium was approved by the US Food and Drug Administration (FDA) on Dec 23, 2016, and approved by the European Medicines Agency’s (EMA) on May 30, 2017, and approved by Pharmaceuticals and Medical Devices Agency of…

ZINPLAVA (BEZLOTOXUMAB), Approved FDA

BEZLOTOXUMAB Biologic License Application (BLA): 761046 Company: MERCK SHARP DOHME Drug Name(s): • ZINPLAVA (BEZLOTOXUMAB) http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761046s000lbl.pdf http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761046Orig1s000ltr.pdf Drug Name Active Ingredient Approval Date FDA-approved use on approval date Zinplava bezlotoxumab 10/21/2016…

VELPATASVIR (GS-5816), GILEAD SCIENCES, велпатасвир, فالباتاسفير , 维帕他韦 ,

VELPATASVIR (GS-5816), GILEAD SCIENCES CAS 1377049-84-7 Molecular Formula: C49H54N8O8 Molecular Weight: 883.00186 g/mol Hepatitis C virus NS 5 protein inhibitors KEEP WATCHING AS I ADD MORE DATA, SYNTHESIS…………… Gilead Sciences, Inc. INNOVATOR Elizabeth M. Bacon, Jeromy J. Cottell, Ashley Anne Katana, Darryl Kato, Evan S. Krygowski, John O. Link, James Taylor, Chinh Viet Tran, Martin Teresa…

VELPATASVIR (GS-5816), GILEAD SCIENCES, велпатасвир, فالباتاسفير , 维帕他韦 ,

  VELPATASVIR (GS-5816), GILEAD SCIENCES

CAS 1377049-84-7

Molecular Formula: C49H54N8O8 Molecular Weight: 883.00186 g/mol

Hepatitis C virus NS 5 protein inhibitors

Gilead Sciences, Inc. INNOVATOR

Elizabeth M. Bacon, Jeromy J. Cottell, Ashley Anne Katana, Darryl Kato, Evan S. Krygowski, John O. Link, James Taylor, Chinh Viet Tran, Martin Teresa Alejandra Trejo, Zheng-Yu Yang, Sheila Zipfel

FDA approves Adlyxin (lixisenatide) to treat type 2 diabetes

    FDA approves Adlyxin to treat type 2 diabetes 07/28/2016 07:53 AM EDT The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes. For Immediate Release July 28, 2016 Release The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a…

FDA approves first MRI-guided focused ultrasound device to treat essential tremor

Exablate Neuro – non-invasive, image-guided alternative for deep brain lesioning     FDA approves first MRI-guided focused ultrasound device to treat essential tremor 07/11/2016 11:28 AM EDT The U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR)…

FDA approves new medication for dry eye disease, Xiidra (lifitegrast ophthalmic solution)

    Xiidra (lifitegrast ophthalmic solution) FDA approves new medication for dry eye disease 07/12/2016 08:48 AM EDT The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1…

FDA approves new diagnostic imaging agent FLUCICLOVINE F-18 to detect recurrent prostate cancer

FLUCICLOVINE F-18 Cyclobutanecarboxylic acid, 1-amino-3-(fluoro-18F)-, trans- [ Molecular FormulaC5H818FNO2 Average mass132.124 Da Axumin (fluciclovine F 18) fluciclovinum (18F) GE-148 NMK36 trans-1-Amino-3-(18F)fluorcyclobutancarbonsäure [German] [ACD/IUPAC Name] trans-1-Amino-3-(18F)fluorocyclobutanecarboxylic acid [ACD/IUPAC Name] UNII-38R1Q0L1ZE…