Author: BEF

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CF News, Therapies
March 19, 2019

Source: FDA news release Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved March 1 by the U.S. Food and Drug Administration. Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis, a serious...

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CF News, Therapies
March 19, 2019

Source: Gilead website February 15, 2012   Important Information Regarding the Availability of Cayston® To the CF Community, Gilead Sciences, Inc., the manufacturer of Cayston, is facing significant and unanticipated challenges manufacturing enough Cayston to meet demand in the United States. Gilead is committed to patient care. To that end, we...

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CF News, Therapies
March 19, 2019

Source: Vertex Pharmaceuticals press release Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has approved KALYDECO™ (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease. KALYDECO (kuh-LYE-deh-koh) is approved for people with CF ages...

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CF News, Therapies
March 19, 2019

Source: Cystic Fibrosis Foundation An expanded access program for a potential new CF drug, Kalydeco™ (VX-770), is now available at participating clinical sites throughout the country for people with the G551D mutation who have highly limited lung function and may benefit from treatment. Vertex Pharmaceuticals, Inc., the...

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CF News, Therapies
March 19, 2019

Source: Vertex Pharmaceuticals press release Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for KALYDECO™ (ivacaftor) and granted the company's request for six-month priority review. KALYDECO targets the defective protein that causes cystic fibrosis (CF)...