The European Commission has approved the use of the CF therapy Kalydeco™ for people with the G551D mutation ages 6 and older in the European Union.
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The U.S. Food and Drug Administration (FDA) announced that it has approved Ultresa™ delayed-release capsules, a pancreatic enzyme replacement therapy. Ultresa (pancrelipase) is manufactured by Aptalis Pharma.
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The European Medicines Agency (EMA) announced today that it has recommended the approval of the CF drug Kalydeco™ for people with the G551D mutation ages 6 and older in the European Union.
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