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Tag Archives: FDA

Teva Announces Launch of Generic Vytorin® in the United States

Wednesday, April 26th 2017 at 8:09pm UTC JERUSALEM–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today announced the launch of generic Vytorin®1 (ezetimibe and simvastatin) tablets in the U.S. Ezetimibe and simvastatin tablets are a prescription medicine that contains two (2) cholesterol lowering medicines, ezetimibe and simvastatin, which are …

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Syros Closes $35 Million Private Financing

Wednesday, April 26th 2017 at 8:05pm UTC CAMBRIDGE, Mass.–(BUSINESS WIRE)– Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, announced today that it has closed a previously announced private financing with a select group of existing and new institutional …

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joimax® Announces 510(k) Clearance for Its Endovapor® 2 Multi Radio Frequency System During Its First Presentation at the Annual Scientific Meeting of the American Association of Neurological Surgeons (AANS) 2017, in Los Angeles

Wednesday, April 26th 2017 at 7:25pm UTC IRVINE, Calif.–(BUSINESS WIRE)– joimax®, the German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endovapor® 2 Multi Radio Frequency …

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PURE Bioscience Receives USDA Permission Letter and FDA FCN Acknowledgement Letter

Thursday, April 27th 2017 at 12:36pm UTC SAN DIEGO–(BUSINESS WIRE)– PURE Bioscience, Inc. (OTCQB: PURE), creator of the patented non-toxic silver dihydrogen citrate (SDC) antimicrobial, announced that the Company has received two required key regulatory notifications on the Company’s path to commercialize PURE Control® as a superior raw poultry processing …

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Melanoma Research Alliance Announces More Than $8.5 million in New Grants for Melanoma Research

Thursday, April 27th 2017 at 2:00pm UTC Scientists in Six Countries to Share Awards Advancing Treatment and Understanding of Melanoma WASHINGTON–(BUSINESS WIRE)– On the cusp of Melanoma Awareness Month (May), the Melanoma Research Alliance (MRA) today announced 34 new research awards to 28 institutions in six countries. The over $8.5 …

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The Medicines Company and Alnylam Pharmaceuticals Announce Agreement with FDA on Phase III Clinical Program for Inclisiran

Wednesday, April 26th 2017 at 11:00am UTC — Pivotal trials will enroll approximately 1,500 subjects randomized to inclisiran versus approximately 1,500 subjects randomized to placebo, with a primary endpoint of LDL-C and an 18-month study period — — NDA submission anticipated at or around the end of 2019 — PARSIPPANY, …

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Samsung GC70 Digital Radiography System Receives FDA 510(k) Clearance

Wednesday, April 26th 2017 at 3:54pm UTC New features support more efficient workflow, flexible configurations to accommodate patients ranging from pediatrics to seniors, and a cutting-edge imaging engine DANVERS, Mass.–(BUSINESS WIRE)– Samsung, an emerging leader in medical imaging technology, announces that the GC70 Digital Radiography (DR) system received FDA 510(k) …

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Revance Therapeutics to Release First Quarter 2017 Financial Results Tuesday, May 9, 2017

Tuesday, April 25th 2017 at 8:05pm UTC – Conference Call Scheduled for Tuesday, May 9, 2017 at 4:30pm ET – NEWARK, Calif.–(BUSINESS WIRE)– Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that the company will release first quarter …

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Samsung Bioepis obtient sa première autorisation de mise sur le marché d’un médicament aux États-Unis avec l’approbation du RENFLEXIS™ (Infliximab-abda) et de toutes les indications éligibles par la U.S. Food and Drug Administration

Wednesday, April 26th 2017 at 2:15am UTC INCHEON, Corée–(BUSINESS WIRE)– Samsung Bioepis Co., Ltd. a annoncé aujourd’hui que la U.S. Food and Drug Administration (FDA) avait approuvé le RENFLEXIS™ (infliximab-abda), un biosimilaire du Remicade®i (infliximab), pour toutes les indications éligibles. Aux États-Unis, le RENFLEXIS™ est prescrit pour le traitement des …

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