- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Thursday, the FDA approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. C3G is a rare disease that causes inflammation and damage to the kidney glomeruli, which are responsible for filtering blood and producing urine. Fabhalta is an oral capsule, taken twice daily. Recommended dosing is available in the prescribing information.
- On Thursday, the FDA issued the latest medical device early alert for Calyxo CVAC Aspiration Systems related to updated instructions for use. This early alert is part of CDRH’s communications pilot to enhance the medical device recall program. The pilot aims to increase transparency and minimize the time between the FDA’s initial awareness of and public communication of potentially high-risk medical device removals or corrections and provide more timely communication to consumers and health care providers.
- On Wednesday, the FDA authorized marketing for the CORIS System, the first automated endoscope channel cleaner that uses the CORIS QUANTUM Cleaning Agent to clean endoscope channels of the Olympus EVIS EXERA III CF-HQ190L colonovideoscope used in colonoscopy, an important screening procedure for colon cancer. The automated cycle delivers the cleaning agent to all endoscope channels, which are then rinsed and purged with air. All external surfaces of the endoscope must still be cleaned and reprocessed according to the endoscope manufacturer’s instructions.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
