Today, the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against LGM Pharma LLC, an importer and distributor...
Company Must Stop Marketing Unauthorized Products or Risk Enforcement Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed...
Today, the U.S. Food and Drug Administration is announcing draft guidance for industry on action levels for lead in processed foods that are intended for babies...
U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose...
U.S. FDA approved Hemgenix, an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, or...
The U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular...
The U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8...
U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products. Each e-cigarette product is packaged to...
FDA issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval...
U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S....
