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BioCardia sought FDA approval for IDE for CMI Trial treating RA

Jan 30, 2018
U.S. Food and Drug Administration (FDA) has approved BioCardia's Investigational Device Exemption for the CardiAMP Chronic Myocardial Ischemia (CMI) Trial to treat patients with…
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CutisPharma confirms FDA’s sanction of FIRVANQ for Clostridium difficile

Jan 30, 2018
U.S FDA has sanctioned CutisPharma's FIRVANQ (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by …
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FDA reviews Theravance Biopharma and Mylan N.V NDA for Revefenacin

Jan 30, 2018
Theravance Biopharma and Mylan N.V confirmed U.S Food and Drug Administration's acceptance for reviewing the company's New Drug Application (NDA) for revefenacin (TD-4208), an…
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FDA extends 510(K) clearance for electroCore’s gammaCore (nVNS)

Jan 30, 2018
electroCore sought 510(k) clearance from the U.S Food and Drug Administration for an extended label for gammaCore (nVNS) as an acute treatment of pain associated with migraine in adult…
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Dr. Jean-Marie Cuillerot, MD appointed CMO for Dragonfly Therapeutics

Jan 30, 2018
Dragonfly Therapeutics welcomes on board Dr. Jean-Marie Cuillerot, MD as its Chief Medical Officer. Dr. Cuillerot set to spearhead clinical development of Dragonfly's natural Killer…
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Emerald Health Information Systems changes to Harris Healthcare Clinical Solutions

Jan 30, 2018
Harris Healthcare asserts that Emerald Health Information Systems will transition from MediSolution, Harris Healthcare's sister company under the Harris umbrella, to Harris Healthcare…
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Letco Medical and ARL Bio Pharma roll out Quality Savings Program

Jan 30, 2018
Supplier of quality compounding products, supplies and equipment, Letco Medical along with ARL Bio Pharma collaborate to roll out their joint Quality Savings Program. The program…
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Medtronic acquires QT Vascular’s Chocolate PTA Balloon Catheter

Jan 30, 2018
Global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, QT Vascular successfully…
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Wuxi and Aravive extend biologics collaboration for AVB-S6-500

Jan 30, 2018
Wuxi Biologics and Aravive Biologics collaborate to extend their biologics manufacturing collaboration, based on the rapid success achieved in the process development, scale-up and cGMP…
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Prometic Life Sciences declares outcome of FDA meet for PBI-4050

Jan 30, 2018
Clinical development Type C meeting with the US Food and Drug Administration (FDA) for its orally active anti-fibrotic lead drug candidate, PBI-4050 was declared by Prometic Life…
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