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Vertex Pharma (VRTX) Announces EMA Validation for Marketing Authorization Application Extension for KAFTRIO in Combination With Ivacaftor

Vertex Pharma (VRTX) Announces EMA Validation for Marketing Authorization Application Extension for KAFTRIO in Combination With Ivacaftor
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City ofUnited kingdomFrance generalUnited statesNew zealandIsabelle fajacVertex pharmaceuticalsVertex pharmaceuticals incorporatedCompanies to workCommittee for medicinal products human useVertex pharmaceuticals nasdaqExchange commissionEuropean commissionEuropean unionEuropean medicines agencyMarketing authorization

Vertex Announces European Medicines Agency Validation for Marketing Authorization Application Extension for KAFTRIO® in Combination With Ivacaftor to Include People With Cystic Fibrosis and Responsive Rare Mutations

-Application to add ~200 non-F508del CFTR mutations to the KAFTRIO® license- -If approved, ~2,800 people with cystic fibrosis in the European Union ages 2 and above could receive a medicine that.

New zealandUnited statesFrance generalCity ofUnited kingdomIsabelle fajacCommittee for medicinal products human useEuropean medicines agencyExchange commissionEuropean commissionVertex pharmaceuticals nasdaqEuropean unionCompanies to workVertex pharmaceuticalsMarketing authorizationMedicinal products

Vertex Receives CHMP Positive Opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor for Children With Cystic Fibrosis Ages 2 Through 5

-If approved, more than 1,200 children would be newly eligible for a medicine that could treat the underlying cause of their disease- .

United kingdomUnited statesCity ofEuropean unionExchange commissionCompanies to workEuropean commissionEuropean medicines agencyCommittee for medicinal products human useVertex pharmaceuticals incorporated nasdaqVertex pharmaceuticals incorporatedMedicinal productsHuman useNia tatsisExecutive vice presidentChief regulatory

Vertex Pharmaceuticals Incorporated: Vertex Receives CHMP Positive Opinion for KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor for Children With Cystic Fibrosis Ages 2 Through 5

Vertex Pharmaceuticals Incorporated: Vertex Receives CHMP Positive Opinion for KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor for Children With Cystic Fibrosis Ages 2 Through 5
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United kingdomUnited statesBaden wübergCity ofVertex pharmaceuticals incorporated nasdaqCommittee for medicinal products human useEuropean medicines agencyEuropean commissionExchange commissionCompanies to workEuropean unionVertex pharmaceuticals incorporatedPharmaceuticals incorporatedMedicinal productsHuman useNia tatsis

Vertex Pharma (VRTX) Receives CHMP Positive Opinion for KAFTRIO in Combination With Ivacaftor

Vertex Pharma (VRTX) Receives CHMP Positive Opinion for KAFTRIO in Combination With Ivacaftor
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

Vertex pharmaceuticals incorporated nasdaqEuropean unionEuropean medicines agencyCommittee for medicinal products human useVertex pharmaceuticals incorporatedMedicinal productsHuman useNia tatsisExecutive vice presidentChief regulatoryQuality officerCombination regimen withProduct characteristics