Latest Updates & News
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 cardiovascular events in adult patients with coronary artery disease (CAD) and to reduce the risk of...
Understanding Dementia Risk in Parkinson’s Disease: What the Latest Research Reveals
What did the research discover? This research investigated how frequently patients with Parkinson’s disease (PD) develop dementia, a feared long-term outcome. Older studies suggested that up to 80% of PD patients develop dementia, but this study used more recent data from two large research cohorts to provide a clearer picture. The study followed 417 participants...
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 time the agency has authorized products commonly referred to as nicotine pouches, which are small...
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 frozen berries with enteric viruses, such as Hepatitis A Virus and Norovirus. This strategy outlines...
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 a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain...
FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials.The draft guidance is intended, when finalized, to assist industry, clinical investigators,...