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 ...
FiercePharma

Vertex Submits Supplemental New Drug Application (sNDA) to U.S. Food and Drug Administration for Use of KALYDECO(R) (ivacaftor) in People 18 and Older with Cystic Fibrosis who ...

Vertex Submits Supplemental New Drug Application (sNDA) to U.S. Food and Drug Administration for Use of KALYDECO(R) (ivacaftor) in People 18 and Older with Cystic Fibrosis who have the R117H Mutation ...
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 ...
Business Wire

Vertex Indirect Tax Solution Recognized as an “Acumatica-Certified Application”

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Vertex, Inc., a leading provider of tax technology and services, announced that its indirect tax solution Vertex ® Indirect Tax O Series ® has been recognized as ...
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 ...
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 ...
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.