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Symkevi/Kalydeco cleared for use in young CF patients pharmatimes
November 30, 2020
The European Commission as approved use of Vertex' Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor) for eligible children with cystic fibrosis (CF) aged 6-11 years.
Vertex’s Kalydeco scores another label extension in EU pharmatimes
November 09, 2020
Vertex has scored approval from the European Commission to extend the label for Kalydeco (ivacaftor) to include the treatment o infants with cystic fibrosis (CF) aged four months or older.
Vertex signs 'landmark' deal with NHS for CF therapy pharmatimes
July 01, 2020
Vertex has reached an agreement with NHS England to reimburse its triple combination therapy Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with Kalydeco (ivacaftor), should the medicine win European approval.
EU expands reach of Vertex' CF drug Kalydeco pharmatimes
June 11, 2020
EU regulators have expanded the treatment scope of Vertex' Kalydeco (ivacaftor) to include a new subset of young patients with cystic fibrosis (CF).
EC approves expanded indication for cystic fibrosis treatment europeanpharmaceuticalreview
December 12, 2019
The European Commission has approved the label extension for KALYDECO® (ivacaftor) to include the treatment of infants with cystic fibrosis between six and 12 months old.
Kalydeco approved by EU for CF in 12-14 month olds pharmatimes
November 30, 2018
Vertex Pharmaceuticals says the European Commission has granted approval of the label extension for Kalydeco, to include the treatment of patients with cystic fibrosis (CF) aged 12 to 24 months.
UK parliamentary enquiry threatens to disclose details of Vertex, NHS negotiations over Orkambi pharmafile
November 12, 2018
The UK House of Commons' Health and Social Care Committee on Friday said that it requested documents from Vertex Pharmaceuticals, NHS England and the
EU approves Vertex’ cystic fibrosis combo pharmatimes
November 05, 2018
The European Commission has approved Vertex’ Symveki in a combination regimen with Kalydeco to treat certain patients with cystic fibrosis (CF)...
FDA Approves Kalydeco americanpharmaceuticalreview
August 17, 2018
Vertex Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane con
Vertex presents real-world data highlighting benefit of CF drug Kalydeco pharmatimes
July 06, 2018
Vertex has presented long-term, observational data highlighting the benefit of Kalydeco in patients with cystic fibrosis.