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Kalydeco News
Vertex Announces FDA Approvals of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for Use in People With CF With Certain Rare Mutations
BOSTON--(BUSINESS WIRE)--December 21, 2020 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) expanded the eligibility for Trikafta...
FDA 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)--Sep. 25, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) for use in...
FDA Approves Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for Cystic Fibrosis Patients Ages 12 and Older Who Have at Least One F508del Mutation
BOSTON--(BUSINESS WIRE)--Oct. 21, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved Trikafta...
FDA Approves Kalydeco (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age
BOSTON--(BUSINESS WIRE)--Apr. 30, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) for use in...
FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene
BOSTON--(BUSINESS WIRE)--Aug. 15, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) to include use in...
FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene
BOSTON--(BUSINESS WIRE) Feb 12, 2018 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Symdeko (tezacaftor/ivacaftor and...
FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 2 to 5 with CFTR Gene Mutations
BOSTON, Mar 18, 2015 --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Kalydeco® for use in children ...
FDA Approves Kalydeco (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation
BOSTON, December 29, 2014 --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug...