FiercePharma

Vertex Submits Application for Priority Review and Approval of KALYDECOTM (VX-770, ivacaftor) in the U.S. as First Potential Med

Vertex Submits Application for Priority Review and Approval of KALYDECO TM (VX-770, ivacaftor) in the U.S. as First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis -- Accelerated ...
Business Wire

Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis

BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug ...
The Boston Globe

FDA rejects Vertex’s application for expanded use of drug

US regulators dealt a blow to Vertex Pharmaceuticals Inc. on Friday, rebuffing the company’s application to sell its first cystic fibrosis drug to a new subset of patients. In what is known as a ...
Nasdaq

Vertex Announces Investigational New Drug (IND) Application for VX-522, mRNA Therapy for People With Cystic Fibrosis, Cleared by FDA

- VX-522 clinical trial in people with CF to initiate in coming weeks - This infographic provides an outline of how we envision this investigational therapy to work and is provided for illustrative ...
Nasdaq

Vertex Announces U.S. FDA Acceptance of Supplemental New Drug Application for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages ...

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its ...
FiercePharma

Vertex Completes New Drug Application for Telaprevir for Hepatitis C | Fierce Pharma

- Submission based on results from Phase 3 studies that showed high SVR (viral cure) rates with telaprevir-based combination therapy compared to approved medicines - CAMBRIDGE, Mass.--(BUSINESS WIRE)- ...
Business Wire

Vertex Announces European Medicines Agency Marketing Authorization Application Validation for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Triple Combination Treatment in ...

LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals (Europe) Limited today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for the VX-445 ...
Reuters

Vertex to begin telaprevir application this summer

NEW YORK, April 21 (Reuters) - Vertex Pharmaceuticals Inc said it will begin the process this summer of seeking U.S. approval for telaprevir, its eagerly anticipated experimental treatment for ...