Medical Device and Pharmaceutical News
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FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol
FDA Approves Lipfendra, the First Oral PCSK9 Inhibitor for High CholesterolLipfendra offers patients a once-daily pill alternative to injectable PCSK9 therapies The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), the first oral medication...
FDA Approves Retevmo for RET Fusion-Positive Solid Tumors
FDA Grants Full Approval to Retevmo for RET Fusion-Positive Metastatic Solid TumorsApproval expands precision medicine option for adults and children with advanced cancers The U.S. Food and Drug Administration (FDA) has granted traditional approval to Retevmo...
FDA Approves Trutakna for Rare Kidney Disease IgA Nephropathy
FDA Approves Trutakna for IgA Nephropathy, First Dual BAFF/APRIL Therapy to Reduce ProteinuriaFirst therapy to target two key immune pathways shown to reduce proteinuria The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Trutakna...
FDA Warning Letters Target Online Ketamine Sellers
Seven Warning Letters Signal Increased FDA Scrutiny The U.S. Food and Drug Administration (FDA) has launched a coordinated enforcement action against websites marketing unapproved ketamine-related drug products, issuing seven Warning Letters on July 7, 2026, to online...
FDA Warns Wild Arabic Herbs Over Product Cancer Claims
FDA Warns Wild Arabic Herbs Over Cancer Claims for Herbal Product FDA issued a warning letter to Wild Arabic Herbs after reviewing the company’s website and determining that its “Edral-17t” product was marketed as an unapproved new drug. FDA cited claims that the...
FDA Warns Amazon for Unapproved Drugs Sold On Its Website
FDA Issues Warning Letter to Amazon for Unapproved Drug Products FDA issued a warning letter to Amazon.com, Inc. after purchasing and reviewing products sold through Amazon’s website and fulfilled through Amazon’s logistics network. The products identified were...
FDA Warns Leading Edge Health Over Unapproved New Drugs
FDA Warning Letter Targets Erectin Stimulating Gel and VigRX Delay Wipes FDA issued a warning letter to Leading Edge Health Inc. after reviewing the company’s website and determining that two sexual health products were being marketed as unapproved new drugs. The...
FDA Targets Online Marketing of Unapproved Drugs
FDA Issues 14 Warning Letters Targeting Online Unapproved Drug Sales The U.S. Food and Drug Administration (FDA) has issued a coordinated series of warning letters targeting companies marketing unapproved drug products online, signaling an intensified enforcement...
FDA Approves First Treatment to Reduce Risk of Acute Pancreatitis
FDA Approves First Treatment Proven to Reduce Acute Pancreatitis Risk in Severe HypertriglyceridemiaAn important example of the distinction between surrogate endpoints and clinical outcomes in drug development The U.S. Food and Drug Administration (FDA) has approved...
One Contaminated Alcohol Pad, Multiple Recalls
A Lesson in Medical Device Supply Chain Quality At first glance, Cardinal Health's recent recall of Webcol™ Alcohol Prep Pads appears straightforward. A commonly used healthcare product was found to be contaminated with Paenibacillus phoenicis, creating a potential...