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....
The U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions in federal district courts against six...
U.S. Food and Drug Administration announced it has awarded 19 new grants and two new contracts totaling more than $38 million in funding over the next...
U.S. Food and Drug Administration approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy...
