Kalydeco
Manufacturing · Massachusetts, United States · 11-50 Employees
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Overview
Headquarters
50 Northern Ave, Boston, Massachusetts, ...Phone Number
(617) 341-6100Website
www.kalydeco.comRevenue
<$5 MillionIndustry
ZI Rank: 1
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ZI Rank
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About Kalydeco
Kalydeco is a pharmaceutical product manufactured for the treatment of cystic fibrosis. The medication is designed to target specific genetic mutations in patients with this condition. Kalydeco operates as a prescription medication that requires oversight from healthcare providers. The company behind Kalydeco produces this specialized pharmaceutical treatment while maintaining compliance with medical regulations and providing comprehensive information about the medication's usage, effects, and safety considerations for patients and healthcare professionals.Explore more
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Kalydeco Tech Stack
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Kalydeco News & Media
Vertex Announces European Commission Approval for SYMKEVI® (tezacaftor/ivacaftor) With KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years
LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension for SYMKEVI® (tezacaftor/ivacaftor) with KALYDECO® (ivacaftor), to include the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutationsFDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age
BOSTON--(BUSINESS WIRE)-- #cf--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data. KALYDECO is already approved in the U.S. and EU for theCHMP Grants Positive Opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO® (ivacaftor) in People Ages 12 and Older With Cystic Fibrosis With the Most Common Genotypes
LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with KALYDECO® (ivacaftor) 150 mg to treat people with cystic fibrosis (CF) ages 12 and older with one F508del mutation and one minimal function mutation (F/MF) or two F508del mutations (F/F) in the cystic fibVertex Announces European Commission Approval for KALYDECO® (ivacaftor) for Children and Adolescents With Cystic Fibrosis Between the Ages of 6 Months and 18 Years With the R117H Mutation in the CFTR Gene
LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension for KALYDECO® (ivacaftor) to include the treatment of children and adolescents with cystic fibrosis (CF), ages 6 months and older and weighing at least 5 kg, who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene – the most common residual function mutation underlying CF. “A little over ei
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Kalydeco is a pharmaceutical product manufactured for the treatment of cystic fibrosis. The medication is designed to target specific genetic mutations in patients with this condition. Kalydeco operates as a prescription medication that requires oversight from healthcare providers. The company behind Kalydeco produces this specialized pharmaceutica... Read More
