Vertex Pharmaceuticals Inc

NASDAQ:VRTXUnited States

Jul 2, 2024

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• FDA Accepts Vertex Pharmaceuticals' New-Drug Application for Combination Therapy to Treat Cystic Fibrosis, from 9:25AM ET on Tuesday Jul 02, 2024 by MT Newswires

  9:25AM ET on Tuesday Jul 02, 2024 by MT Newswires
  Companies Mentioned: VRTX
  09:25 AM EDT, 07/02/2024 (MT Newswires) -- Vertex Pharmaceuticals (VRTX) said Tuesday that the US Food and Drug Administration has accepted its new-drug application for the combination therapy of vanzacaftor, tezacaftor, and deutivacaftor to treat p...

• DJ Vertex Gets Speedy FDA Review of Vanza Triple Cystic Fibrosis Therapy, from 8:59AM ET on Tuesday Jul 02, 2024 by Dow Jones

  8:59AM ET on Tuesday Jul 02, 2024 by Dow Jones
  Companies Mentioned: VRTX
  
  By Colin Kellaher
  
  Vertex Pharmaceuticals has won Food and Drug Administration priority review for its application seeking approval of a triple combination therapy for the genetic lung disease cystic fibrosis.
  

• Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis, from 8:33AM ET on Tuesday Jul 02, 2024 by Business Wire

  8:33AM ET on Tuesday Jul 02, 2024 by Business Wire
  Companies Mentioned: VRTX

  --- EU Marketing Authorization Application (MAA) submission also validated by European Medicines Agency (EMA)

  Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for investigational once-daily vanzacaftor/tezacaftor/deutivacaftor triple combination therapy (vanza triple) for people living with cystic fibrosis (CF) ages 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene responsive to the vanza triple. Vertex used a priority review voucher for this submission reducing the review time from 10 months to 6 months, resulting in a Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025.

• Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis, from 8:33AM ET on Tuesday Jul 02, 2024 by Dow Jones

  8:33AM ET on Tuesday Jul 02, 2024 by Dow Jones
  Companies Mentioned: VRTX
  
  - Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 --
  
  - EU Marketing Authorization Application (MAA) submission also validated by European Medicines Agency (EMA)