FDA

FDA

FDA News Update: Groundbreaking Eye Gene Therapy Approved, Epinephrine Nasal Spray Expanded

<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="2025-03-07T05:00:00Z">March 07, 2025</time&

FDA

FDA News Update: First Xarelto Generics Approved, New Testosterone Warnings, and Stroke Treatment Approval

<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="2025-03-04T21:45:00Z">March 04, 2025</time&

FDA

FDA News Update: First Nicotine Pouches Receive Marketing Authorization Under Premarket Review

For Immediate Release:                  January 16, 2025 </dl> </div> Today, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. This is the first time the agency has

FDA

FDA News Update: Food Safety, Medical Advances, and New Regulatory Actions

<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="2025-01-17T20:30:00Z">January 17, 2025</time&

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FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials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FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices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