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Industry News: FDA Announces Additional Steps to Modernize Clinical Trials
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The FDA announced the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections.
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Dr. D. Ross Camidge and Dr. Peter Kabos Win University of Colorado Recognition Awards
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Dr. Peter Kabos, MD, Associate Professor, Division of Medical Oncology and Dr. D. Ross Camidge, MD, PhD, Professor of Medicine/Oncology were recently honored by the University of Colorado’s Division of Medical Oncology.
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Industry News: Topline Results from Phase 3 Trial of Amyloid-Clearing Drug Donanemab
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Approval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
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Industry News: The FDA Granted an Investigational Device Exemption Approval for Sirolimus Coated Balloon For the Treatment of Small Vessels In Coronary Arteries
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Approval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
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Industry News: U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine
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Approval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
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Industry News: Pharma Industry Consortium Completes Brain Wave Study of Ketamine Effects on Healthy Subjects
Successful completion of a pharma industry-sponsored study to measure the electrophysiologic effects of ketamine on healthy brain function.
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