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Date Title and Summary Additional Formats
Toggle Summary Vertex Announces FDA Clearance of Investigational New Drug (IND) Application for VX-880, a Novel Cell Therapy for the Treatment of Type 1 Diabetes (T1D)
- Vertex will initiate a Phase 1/2 clinical trial in first half of 2021 - - VX-880 is the first stem cell-derived therapy evaluating fully differentiated pancreatic islet cells for the treatment of T1D - BOSTON --(BUSINESS WIRE)--Jan. 28, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
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Toggle Summary 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
- More than 600 people with certain rare CF mutations are now eligible for TRIKAFTA, SYMDEKO or KALYDECO - BOSTON --(BUSINESS WIRE)--Dec. 21, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) expanded the eligibility for TRIKAFTA ®
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Toggle Summary Vertex Announces Expansion of Reimbursement Agreement With NHS England to Include KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO® (ivacaftor)
-CF patients in England will be among the first in Europe to benefit from access to KAFTRIO ® , if the medicine is approved by the European Commission - LONDON --(BUSINESS WIRE)--Jun. 30, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has expanded its
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Toggle Summary 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 treats the underlying cause of their disease for the first time- LONDON --(BUSINESS WIRE)--Nov.
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Toggle Summary Vertex Announces European Medicines Agency Type II Variation Marketing Authorization Application Validation for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination with ivacaftor in People with One Copy of the F508del Mutation
LONDON --(BUSINESS WIRE)--Sep. 14, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the European Medicines Agency (EMA) has validated a Type II Variation Marketing Authorization Application (MAA) for the expanded indication of KAFTRIO ®* (ivacaftor/tezacaftor/elexacaftor)
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Toggle Summary Vertex Announces European Medicines Agency Marketing Authorization Application Validation for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Triple Combination Treatment in Cystic Fibrosis
- Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations - LONDON --(BUSINESS WIRE)--Oct.
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Toggle Summary Vertex Announces European Commission Approval for SYMKEVI® (tezacaftor/ivacaftor) With KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years
- The combination therapy is a new treatment option for CF patients who are homozygous for F508del - - The only medicine to treat the underlying cause of CF in this age group with one F508del mutation and one of 14 residual function mutations - LONDON --(BUSINESS WIRE)--Nov.
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Toggle Summary Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
Lumacaftor/ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis for approximately 1,500 children aged 2 to 5 with two copies of the F508del mutation LONDON --(BUSINESS WIRE)--Jan. 21, 2019-- Vertex Pharmaceuticals (Europe) Limited today
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® to Treat Infants With Cystic Fibrosis Ages 1 Month and Older
-   KALYDECO   ® is the first and only medicine approved in the EU in this age group to treat the underlying cause of cystic fibrosis for specific mutations in the CFTR gene - LONDON --(BUSINESS WIRE)--Apr. 26, 2024-- Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) to Treat Patients with Cystic Fibrosis Aged 12 to <24 months with Certain Mutations in the CFTR Gene
Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in these young patients LONDON --(BUSINESS WIRE)--Nov. 29, 2018-- Vertex Pharmaceuticals (Europe) Limited today announced that the European Commission has granted approval of the label
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