Kalydeco was initially approved in 2012 to treat patients aged over six with a single mutation of the cystic fibrosis transmembrane regulator (CFTR) gene - known as G551D - which affects around ...
US regulators have expanded the label for Vertex’s cystic fibrosis drug, Kalydeco, extending its use to include children aged 12-24 months with certain genetic mutations. The FDA said Kalydeco ...
Lupin also received tentative approval from the FDA for ivacaftor oral granules, 25 mg, 50 mg and 75 mg per unit dose packet, which is a generic of Vertex’s Kalydeco. Lupin is the exclusive ...
In March 2022, the Competition Commission launched an investigation into Vertex, alleging excessive pricing and exclusionary practices in its supply of cystic fibrosis drugs, including Kalydeco ...
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