FiercePharma

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 ...
FierceBiotech

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 ...
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 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 ...
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 ...
MarketWatch

Vertex Pharma to Submit Kidney-Disease Drug Application to FDA by Year-End

Vertex Pharmaceuticals plans by year-end to submit part of a license application to regulators for its kidney-disease treatment, and to have the full application submitted by first half of next year.
Investing

FDA accepts Vertex's new cystic fibrosis therapy application

BOSTON – Vertex Pharmaceuticals (NASDAQ:VRTX) Incorporated (NASDAQ:VRTX) has announced the U.S. Food and Drug Administration's (FDA) acceptance of its New Drug ...
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 ...