FDA Roundup: April 30, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development of Safe and Effective Biosimilars,” by Sarah Yim, Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., and Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research. This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that treat a wide range of chronic and severe illnesses, and which have already had an important impact on patient access. Bio...