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Pregnancy Category Risk cannot be ruled out
The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and...
Kalydeco (ivacaftor) has been approved by the U.S. Food and Drug Administration to treat the root cause of a rare form of the inherited disease cystic...
Dec 15, 2011 - Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application...
- New data at North American CF Conference showed a reduction in sweat chloride when KALYDECO was added to VX-809 in people with the F508del mutation – -...
- Additional presentations at the North American CF Conference include data from PERSIST that showed sustained safety and efficacy of KALYDECO through 60...
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