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U.S. approves new drug for rare cystic fibrosis

WASHINGTON — US regulators on Tuesday approved Kalydeco, a new, gene-targeted drug treatment for people who have a rare kind of the incurable lung disease cystic fibrosis. Made by the Massachusetts-based Vertex Pharmaceuticals, Kalydeco (ivacaftor) was approved by the US Food and Drug Administration on a fast-track for drugs that…

US approves first heart pump for children

The US Food and Drug Administration has approved a first mechanical cardiac assist device for children that can help keep patients alive as they await a transplant. The EXCOR Pediatric System, made by German company Berlin Heart, can be sized to fit young people from newborns to teenagers. “This is…

U.S. approves drug for middle-of-the-night insomniacs

The US Food and Drug Administration, for the first time, approved Wednesday medication specifically designed for those who wake up in the middle of the night and cannot fall back to sleep. Intermezzo, manufactured by Transcept Pharmaceuticals of California, is a lower-dose formulation of zolpidem, first approved in the United States in…

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