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MRI News Service:
'Gadobutrol'
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Result: Searchterm 'Gadobutrol' found in 12 news
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GE HealthCare introduces new MRI agent Pixxoscan
''GE HealthCare has expanded its magnetic resonance imaging (MRI) contrast agent portfolio with the launch of Pixxoscan (gadobutrol). Designed to enable the visualisation of abnormal structures ...'
Friday, 28 April 2023   by www.medicaldevice-network.com
Gadopiclenol: positive results for Phase III clinical trials
''Guerbet, today announced positive results from two Phase III clinical studies comparing the diagnostic efficacy and safety of Gadopiclenol to Gadobutrol in a wide range of indications, covering ...'
Wednesday, 24 March 2021   by www.guerbet.com
Bayer receives European approval for Gadovist (gadobutrol) for use in pediatric patients less than 2 years of age
''Approval based on data demonstrating the pharmacokinetic and safety profiles of Gadovist at standard dose (0.1 mmol/kg) were similar to adults and children 2 years of age and older / Diagnostic use in approved indications has been expanded to include use ...'
Tuesday, 14 July 2015   by pipelinereview.com
FDA approves Bayer's Gadavist® (gadobutrol) injection as the first magnetic resonance contrast agent for pediatric patients less than 2 years of age
''Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use with magnetic resonance imaging (MRI) in pediatric patients less than 2 years of age, including term neonates, to ...'
Monday, 5 January 2015   by www.prnewswire.com
New data presented at RSNA on use of Bayer's Gadavist® (gadobutrol) injection in children less than 2 years of age
''Data from a Bayer study in children (infants) less than 2 years of age will be presented today at the 2014 Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting.1 The primary endpoint of the study was the evaluation of the ...'
Wednesday, 3 December 2014   by www.prnewswire.com
FDA approves Bayer's Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the United States
''Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Gadavist® (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast ...'
Thursday, 12 June 2014   by www.prnewswire.com
U.S. FDA Approves Bayer's Gadobutrol Injection for MRI of the Central Nervous System
''Bayer HealthCare Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved Bayer's gadobutrol injection Gadavist™ (gadobutrol), a 1.0 molar macrocyclic gadolinium-based contrast agent (GBCA) for intravenous use in ...'
Tuesday, 15 March 2011   by viva.vita.bayerhealthcare.de
FDA Advisory Committee Recommends Approval of Bayer Corporation (BAY)'s Gadobutrol Injection for MRI of the Central Nervous System
''Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously that clinical trial and postmarketing data for gadobutrol ...'
Friday, 21 January 2011   by www.biospace.com
FDA Panel to Discuss CNS Contrast Agent
''The FDA's panel of outside neurology experts will meet Friday to discuss risks for a serious skin disorder presented by a new, contrast agent for MRI scans of the central nervous system. The product -- gadobutrol, made by Bayer -- is one of a class ...'
Thursday, 20 January 2011   by www.medpagetoday.com
FDA Accepts New Drug Application For Gadovist® 1.0 Injection In Magnetic Resonance Imaging
''Bayer Schering Pharma AG, Berlin, Germany, announced today that the Food and Drug Administration (FDA) has accepted for filing a New Drug Application to the U.S. for gadobutrol injection, a gadolinium-based contrast agent for magnetic resonance ...'
Friday, 6 August 2010   by www.medicalnewstoday.com
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