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FDA Roundup: January 06, 2023Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted an update that the agency is closely monitoring the emergence of... -
FDA Grants Accelerated Approval for Alzheimer’s Disease TreatmentToday, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of a new category of... -
FDA Roundup: December 30, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced, through a Constituent Update and corresponding rule in the F... -
FDA Roundup: December 23, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA announced that the VQIP Application Portal would open on January 1... -
FDA Approves New HIV Drug for Adults with Limited Treatment OptionsToday, 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... -
FDA Roundup: December 20, 2022Today, 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... -
FDA Provides Update on External Evaluation to Strengthen Agency’s Tobacco ProgramEarlier this year, I commissioned an external evaluation of the U.S. Food and Drug Administration’s Tobacco Program, to be conducted by an external expert panel facilitated by the Reagan-Udall Foundat... -
FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder CancerToday, 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... -
Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19On Jan. 26, 2023, the U.S. Food and Drug Administration will hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider whether and how the composition for... -
FDA Roundup: December 13, 2022Today, 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...