For Immediate Release: December 22, 2022 Today, the 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 HIV infections …
For Immediate Release: December 20, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the agency published a piece for FDA Voices: “Office of Digital Transformation’s New Focus on …
FDA News Release Company prohibited from distributing drug products that violate the law For Immediate Release: December 19, 2022 Today, the U.S. District Court for the Western District of Oklahoma entered a consent decree against Qualgen LLC, an …
For Immediate Release: December 19, 2022 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration Earlier this year, I commissioned an external evaluation of the U.S. Food and Drug Administration’s Tobacco …
For Immediate Release: December 16, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA released a draft update to guidance for industry (GFI) #152, “Evaluating the Safety of …
For Immediate Release: December 16, 2022 Today, the U.S. Food and Drug Administration approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating (cannot multiply in human cells) adenoviral vector based gene therapy indicated for the treatment …
For Immediate Release: December 16, 2022 Statement From: Peter Marks, M.D., PhD. Director - Center for Biologics Evaluation and Research (CBER) On Jan. 26, 2023, the U.S. Food and Drug Administration will hold a meeting of its Vaccines and Related …
For Immediate Release: December 13, 2022 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 updated the device shortage list to remove medical gloves (product codes LYY, LYZ, …
FDA News Release Rebyota Approved for the Prevention of Recurrence of Clostridioides difficile Infection in Adults For Immediate Release: November 30, 2022 Today, the U.S. Food and Drug Administration approved Rebyota, the first fecal microbiota product …
For Immediate Release: November 29, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued two guidance documents about food allergen labeling requirements to help the …
For Immediate Release: November 22, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an emergency use authorization (EUA) for the Lucira COVID-19 and Flu Test for …
For Immediate Release: November 22, 2022 Today, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX …
For Immediate Release: November 18, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Yesterday, the FDA provided an update on the Philips Respironics (Philips) June 2021 recall. …
For Immediate Release: November 17, 2022 Today, 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 years and older who currently have stage 2 …
For Immediate Release: November 17, 2022 Today, 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 disease or related …
For Immediate Release: November 16, 2022 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration Susan T. Mayne, Ph.D. Director - Center for Food Safety and Applied Nutrition (CFSAN) The world is …
FDA News Release Companies Must Stop Marketing Unauthorized Products or Risk Enforcement For Immediate Release: November 16, 2022 Today, the U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 …
For Immediate Release: November 15, 2022 English Hari ini, Badan Pengawas Obat dan Makanan AS mengumumkan kemajuan yang belum pernah terjadi sebelumnya dalam pencegahan penyakit yang ditularkan melalui makanan melalui finalisasi aturan untuk melacak …
For Immediate Release: November 15, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an Emergency Use Authorization (EUA) to Roche Molecular Systems, Inc. for the …
For Immediate Release: November 15, 2022 Today, the U.S. Food and Drug Administration announced an unprecedented advancement in foodborne illness prevention through the finalization of a rule to more effectively trace contaminated food through the food …
