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 ...
PharmiWeb

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

- Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in people ...
technologynetworks

Vertex and CRISPR Therapeutics Announce MHRA Marketing Authorisation Application Validation for CRISPR/Cas9 Gene-Edited Therapy

Vertex Pharmaceuticals (Europe) and CRISPR Therapeutics (NASDAQ: CRSP) have announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has validated the Marketing Authorisation ...
PharmiWeb

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

- Novel, inhaled mRNA therapy intended for the ~5,000 people with CF who cannot benefit from CFTR modulators - - VX-522 clinical trial in people with CF to initiate in coming weeks - BOSTON--(BUSINESS ...
Business Wire

Vertex Announces FDA Clearance of Investigational New Drug Application for VX-264, a Novel Encapsulated Cell Therapy for the Treatment of Type 1 Diabetes

BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) ...
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 ...