David Randall

FDA

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

<div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">For Immediate Release:</dt> <dd class="cell-2_1"><time datetime="2025-01-30T22:45:00Z">January 30, 2025</time&

FDA

FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials

<div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">For Immediate Release:</dt> <dd class="cell-2_1"><time datetime="2025-01-06T16:30:00Z">January 06, 2025</time&

FDA

FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions

<div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">For Immediate Release:</dt> <dd class="cell-2_1"><time datetime="2025-01-06T15:25:00Z">January 06, 2025</time&

FDA

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices

<div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">For Immediate Release:</dt> <dd class="cell-2_1"><time datetime="2025-01-06T15:10:00Z">January 06, 2025</time&

FDA

FDA Roundup: December 27, 2024

For Immediate Release: December 27, 2024Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: * On Thursday, the FDA announced recommended changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder. The recommended changes intend to encourage the

FDA

FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes

For Immediate Release:  December 23, 2024Today, the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes

FDA

FDA Approves First Medication for Obstructive Sleep Apnea

For Immediate Release:  December 20, 2024Today, 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

FDA

FDA Roundup: December 20, 2024

For Immediate Release:  December 20, 2024Today, 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

FDA

FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities

<div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">For Immediate Release:</dt> <dd class="cell-2_1"><time datetime="2024-12-20T14:20:00Z">December 20, 2024</time&

FDA

Skip the Antibacterial Soap; Use Plain Soap and Water

<figure> <div> Image </figure> Español When 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

FDA

Know When and How to Use Antibiotics, and When to Skip Them

[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

FDA

FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease

<div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">For Immediate Release:</dt> <dd class="cell-2_1"><time datetime="2024-12-18T21:35:00Z">December 18, 2024</time&