Today, Vertex Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has accepted its application to expand Trikafta® (elexacaftor/tezacaftor/ivacaftor) to include children ages 6-11 years old with cystic fibrosis who have at least one F508del or a mutation in the CFTR gene that is responsive based on in vitro data. The FDA has granted priority review of the application and has indicated that it will make a decision by June 8, 2021.
Jan. 26, 2021
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2 min read
Positive results from a study of ivacaftor (Kalydeco®) in children ages 1 to 2 were announced today.
Dec. 7, 2017
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2 min read
Two Phase 3 clinical trials of tezacaftor (VX-661) in combination with ivacaftor (Kalydeco®) showed positive results, Vertex Pharmaceuticals announced today.
March 28, 2017
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4 min read
Update: On February 3, 2017, the Cystic Fibrosis Foundation divested its remaining ownership stake in CF Services Inc., a specialty pharmacy. The pharmacy is now fully owned by Walgreens.
Feb. 3, 2017
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3 min read
Aim is to Provide Cystic Fibrosis Patients Enhanced Access to Medications and Expanded Pharmacy Services
Oct. 2, 2012
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4 min read
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.
March 2, 2012
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1 min read
July 15, 2008
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1 min read