News

FiercePharma11y

Vertex Submits Supplemental New Drug Application (sNDA) to U.S. Food and Drug Administration for KALYDECO™ (ivacaftor) Monotherapy for People with Non-G551D Gating Mutations

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug ...
FierceBiotech13y

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

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 Wire1y

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 Globe9y

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 ...
Nasdaq4y

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 ...
Nasdaq2y

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 ...