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 ...
The Food and Drug Administration has given Lupin a tentative nod for two new generics. The first medication is loteprednol etabonate ophthalmic gel, 0.38%, which is a generic of Bausch & Lomb’s ...
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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