For Immediate Release: December 20, 2024 Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity. “Today’s approval marks the first drug treatment option for certain...
For Immediate Release: December 20, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided answers to a set of FAQs about software functions that may be described as clinical decision support (CDS). The FAQs are intended to help sponsors identify whether their CDS software may or...
For Immediate Release: December 20, 2024 The U.S. Food and Drug Administration approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow) is needed to avoid imminent limb loss, and autologous vein graft is not...
Image EspañolWhen you buy soaps and body washes, do you reach for products labeled “antibacterial” hoping they’ll keep your family safer? Do you think those products will lower your risk of getting sick, spreading germs or being infected?According to the U.S. Food and Drug Administration, currently there isn’t sufficient evidence to show that over-the-counter (OTC)...
[embedded content] Español Antibiotics are powerful medications that save countless lives every day. But they’re not the answer for every illness. Antibiotics treat only some infections caused by bacteria – and none caused by viruses. Most often, antibiotics work by killing the targeted bacteria or by making it difficult for the bacteria to multiply. Talk to your...
For Immediate Release: December 18, 2024 Today, the U.S. Food and Drug Administration approved Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients 2 months of age and older.Ryoncil is the first...