The European Commission has approved the cystic fibrosis drug Orkambi® for people with two copies of the F508del mutation ages 12 and older in the European Union.
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April 11, 2008
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Dec. 15, 2011
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The Institute for Clinical and Economic Review (ICER) recently posted a draft evidence report to outline their initial assessment of the clinical effectiveness and value of CFTR modulators, including elexacaftor/tezacaftor/ivacaftor (TrikaftaTM). The document is open for public comment through March 18.
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Feb. 20, 2020
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2 min read
The U.S. Food and Drug Administration (FDA) approved the use of lumacaftor/ivacaftor (Orkambi®) today for children with cystic fibrosis ages 6 to 11, who have two copies of the F508del mutation.
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Sept. 28, 2016
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March 4, 2011
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2 min read
The U.S. Food and Drug Administration (FDA) has decided not to approve the use of ivacaftor (Kalydeco®) to treat people with cystic fibrosis ages 2 and older who have one of 23 rare CF mutations, known as “residual function” mutations.
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Feb. 5, 2016
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2 min read