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 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.
The U.S. House of Representatives and the Senate have both incorporated the Expanding and Promoting Expertise in Review of Rare Treatments Act (EXPERRT Act), championed by the CF Foundation, as part of a legislative package to reauthorize the U.S. Food and Drug Administration's (FDA) system for evaluating new prescription drugs and devices.
On March 8, more than 40 Cystic Fibrosis Foundation volunteers from across the nation came together on Capitol Hill to speak out on behalf of their friends and family members with cystic fibrosis.
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.