FDA

For Immediate Release: February 28, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA approved Odactra to include use in individuals 5 through 11 years of age to treat house dust mite induced nasal inflammation (allergic rhinitis), with or without eye inflammation...

For Immediate Release: April 22, 2025 The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant milestone in the administration’s broader initiative to Make America Healthy Again. The FDA is taking...

For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA’s Learning and Education to ADvance and Empower Rare Disease Drug Developers initiative published two new videos titled “Understanding the Importance of Endpoints in Rare Disease Drug Development”...

For Immediate Release: April 10, 2025 Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation...

For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors (neutralizing antibodies).“Today’s...

For Immediate Release: April 01, 2025 Renowned surgeon-scientist and health policy expert, Martin A. Makary, M.D., M.P.H., took the oath of office to become the 27th Commissioner of Food and Drugs. Dr. Makary was confirmed by a bipartisan vote of the U.S. Senate.“I am pleased to welcome Dr. Makary to the U.S. Department of Health and Human Services and the Food and...