News and Press Releases
Research | Drug Pipeline | Medications FDA Accepts Vertex Application for Expansion of Trikafta to Include Children ages 6-11

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 | 2 min read
Medications Study of Ivacaftor in Children Ages 1 to 2 Shows Positive Results

Positive results from a study of ivacaftor (Kalydeco®) in children ages 1 to 2 were announced today.

Dec. 7, 2017 | 2 min read
Medications Positive Results from Two Phase 3 Clinical Studies of Tezacaftor (VX-661) and Ivacaftor

Two Phase 3 clinical trials of tezacaftor (VX-661) in combination with ivacaftor (Kalydeco®) showed positive results, Vertex Pharmaceuticals announced today.

March 28, 2017 | 4 min read
About the CF Foundation | Drug Pipeline | Medications FDA Approves Ultresa — Pancreatic Enzyme Therapy for People with CF

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 | 1 min read