February's FDA approvals feature advancements in cardiology, neurology, infectious diseases, and rare disorders, including the first trials for genetically modified pig kidney transplants and novel treatments for Parkinson’s disease and spinal muscular atrophy.
The finalization of new criteria for the "healthy" nutrient content claim on food labels has been delayed, allowing more time for regulatory review of standards that could significantly influence labeling practices and help reduce diet-related chronic diseases.
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FDA declares resolution of nationwide semaglutide injection shortage and outlines 60 to 90 day transition periods for compounding facilities while other GLP-1 medications remain in limited supply.
Mesalamine 800 mg delayed-release tablets have been launched, and FDA approval has been granted for lenalidomide, with plans for entry into the U.S. generic market in 2026.
Upadacitinib, the first oral treatment for Crohn's disease, has been approved by the Food and Drug Administration. The approval came in part through a Mount Sinai-led clinical trial that showed it to be more efficacious than placebo.