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FDA New Update: New Treatments, Safety Alerts, and Medical Advancements
For Immediate Release: February 28, 2025 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 Odactra to include use in individuals 5 through 11 years of age to treat house dust...

FDA News Update: Groundbreaking Eye Gene Therapy Approved, Epinephrine Nasal Spray Expanded
For Immediate Release: March 07, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Wednesday, the FDA approved Encelto (revakinagene taroretcel-lwey), an allogeneic encapsulated cell-based gene...

FDA News Update: First Xarelto Generics Approved, New Testosterone Warnings, and Stroke Treatment Approval
For Immediate Release: March 04, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Monday, the FDA approved the first generics of Xarelto (rivaroxaban), 2.5 mg, tablets to reduce the risk of major...

FDA News Update: First Nicotine Pouches Receive Marketing Authorization Under Premarket Review
For Immediate Release: January 16, 2025 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...

FDA News Update: Food Safety, Medical Advances, and New Regulatory Actions
For Immediate Release: January 17, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA announced the release of a new prevention strategy aimed at combating the contamination of fresh and...

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
For Immediate Release: January 30, 2025 Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting...

FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials.The...

FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,...