Antibiotics fight infections caused by bacteria. They should not be used to treat infections caused by viruses (such as the flu) or types of fungi, which include yeasts and molds.
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Having already been underwhelmed by Orkambi® and Symdeko®, I was skeptical about whether the triple-combination therapy would live up to the hype. However, after a month of being on Trikafta®, I feel improvements in my lung function, weight, and overall energy.
Today, Vertex Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has accepted its application to expand Trikafta® (elexacaftor/tezacaftor/ivacaftor) to include children ages 6-11 years old with cystic fibrosis who have at least one F508del or a mutation in the CFTR gene that is responsive based on in vitro data. The FDA has granted priority review of the application and has indicated that it will make a decision by June 8, 2021.
Update: On February 3, 2017, the Cystic Fibrosis Foundation divested its remaining ownership stake in CF Services Inc., a specialty pharmacy. The pharmacy is now fully owned by Walgreens.
Aim is to Provide Cystic Fibrosis Patients Enhanced Access to Medications and Expanded Pharmacy Services
When the news of the Trikafta™ approval came out, I was simultaneously excited for people with CF that would benefit and disappointed that another new medicine is passing me by. But, hearing about the next wave of research into a cure for ALL people with CF has me looking forward to the future.
The U.S. Food and Drug Administration (FDA) announced that it has approved Ultresa™ delayed-release capsules, a pancreatic enzyme replacement therapy. Ultresa (pancrelipase) is manufactured by Aptalis Pharma.
Positive results from a study of ivacaftor (Kalydeco®) in children ages 1 to 2 were announced today.
Two Phase 3 clinical trials of tezacaftor (VX-661) in combination with ivacaftor (Kalydeco®) showed positive results, Vertex Pharmaceuticals announced today.