Today we received the exciting news that the U.S. Food and Drug Administration has approved Orkambi for people with cystic fibrosis ages 12 and older who have two copies of the F508del gene mutation, the most common CF mutation.
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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.
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.
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.
On Aug. 27, leaders from the Cystic Fibrosis Foundation, along with several people from the CF community, participated in a virtual public meeting hosted by the Institute for Clinical and Economic Review to provide insights and expertise on the value of CFTR modulators.