The U.S. Food and Drug Administration has approved a device, called RELiZORB®, that helps break down beneficial fats in supplemental nutrition provided via G-tubes.
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Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation, announced today a $5 million development award to Corbus Pharmaceuticals for a potential new therapy to reduce lung inflammation in people with CF.
Clinical trials that test potential drugs and therapies in people with cystic fibrosis are a major part of CF research. They take place at Cystic Fibrosis Foundation-accredited care centers all over the United States and enroll people with CF of all ages.
When you are deciding whether to join a clinical trial, you should consider logistics.
Robust funding for the National Institutes of Health helps ensure innovation in basic research and a full pipeline of cystic fibrosis therapies. A well-resourced U.S. Food and Drug Administration helps advance therapies that are safe and effective.
The U.S. Food and Drug Administration approved an important new inhaled
The U.S. Food and Drug Administration (
An advisory panel of the U.S. Food & Drug Administration (
As part of the drug evaluation process, the FDA convened an advisory committee to provide input to the agency on liprotamase, as it does for other drugs.
At today's meeting, data on liprotamase were presented by the FDA and by Eli Lilly and Company, which is developing the drug.
“We appreciate the feedback the committee has provided, and we will continue to work with the FDA to address the questions raised in the meeting as the agency moves toward a final decision on the application,” said Eiry Roberts, M.D., vice president, Autoimmune, Bone-Muscle-Joint, Liprotamase Product Development at Lilly, in a company press statement.
Said Robert J. Beall, Ph.D., president and CEO of the CF Foundation: “We look forward to FDA's final decision and recommendations regarding this drug. We will work with all parties to ensure that safe and effective new drugs are available to CF patients.”
The FDA is expected to rule on liprotamase late this spring.