Archive for 2022

FDA Roundup: December 30, 2022

December 30, 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 announced, through a Constituent…

FDA Roundup: December 23, 2022

December 23, 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 announced that the…

FDA Approves New HIV Drug for Adults with Limited Treatment Options

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…

FDA Roundup: December 20, 2022

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 Provides Update on External Evaluation to Strengthen Agency’s Tobacco Program

Earlier 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…

FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer

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…

Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19

On 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…

FDA Roundup: December 13, 2022

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…

Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use…

FDA Provides Update on External Evaluation to Strengthen Agency’s Human Foods Program

In July, I commissioned an external evaluation of the U.S. Food and Drug Administration’s Human Foods Program, including the Office of Food Policy and Response…