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Cystic Fibrosis News (Page 2)
FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene
BOSTON--(BUSINESS WIRE) Feb 12, 2018 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Symdeko (tezacaftor/ivacaftor and...
FDA Approves Orkambi (lumacaftor/ivacaftor) for Use in Children with Cystic Fibrosis Ages 6 through 11 who have Two Copies of the F508del Mutation
BOSTON--(BUSINESS WIRE) September 28, 2016 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Orkambi...
FDA Approves Orkambi (lumacaftor/ivacaftor) for Cystic Fibrosis
July 2, 2015 – The U.S. Food and Drug Administration today approved the first drug for cystic fibrosis directed at treating the cause of the disease in people who have two copies of a specific...
FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 2 to 5 with CFTR Gene Mutations
BOSTON, Mar 18, 2015 --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Kalydeco® for use in children ...
FDA Approves Kalydeco (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation
BOSTON, December 29, 2014 --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug...
FDA Approves PulmoFlow's Kitabis Pak Tobramycin & Nebulizer Combination for Cystic Fibrosis
RICHMOND, Va., Dec. 3, 2014 /PRNewswire/ – On Tuesday, the FDA granted final approval of PulmoFlow, Inc.'s New Drug Application for Kitabis Pak – a co-packaging of generic tobramycin inhalation s...
FDA Medwatch Alert: Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product
ISSUE: Ben Venue Laboratories notified health professionals and their medical care organizations of a nationwide product recall of Acetylcysteine Solution 10%, manufactured for Roxane Laboratories,...
FDA Approves TOBI Podhaler to Treat a Type of Bacterial Lung Infection in Cystic Fibrosis Patients
March 22, 2013 – The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a...
Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules
BETHLEHEM, Pa., May 18, 2012 /PRNewswire/ – Digestive Care, Inc. (DCI), announced that the company has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for...
FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis
TUESDAY, January 31, 2012 – The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who...
U.S. Food and Drug Administration Approves Cayston (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb 23, 2010 - Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston (aztreonam for...
FDA Medwatch Alert: Unapproved Compounded Inhalation Drugs
[Posted 08/10/2006] The FDA notified consumers and healthcare professionals that RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services are manufacturing and distributing unapproved...
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