- Location
Kalydeco
"-
Vertex Pharmaceuticals Has Received Approval From The US Food and Drug Administration
Feb 25, 2014US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic ...
Tags: FDA Approval, Vertex, Kalydeco sNDA
-
European Commission Has Approved Vertex Pharmaceuticals's Kalydeco
Jul 30, 2012The European Commission has approved Vertex Pharmaceuticals' Kalydeco (ivacaftor) to treat the underlying cause of cystic fibrosis in people with a specific genetic mutation (G551D). The approval is based on positive findings from two ...
Tags: european approval, kalydeco, cystic fibrosis
-
CHMP Has Issued a Positive Opinion
May 28, 2012The European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Vertex Pharmaceuticals' Kalydeco (ivacaftor) to treat the underlying cause of cystic fibrosis (CF). Kalydeco is indicated for people ...
Tags: Kalydeco, cystic fibrosis, clinical study
