FDA News Recap: April 2025

Key Takeaways

• Atrasentan, inebilizumab, and maralixibat received FDA approval, highlighting advancements in IgA nephropathy, IgG4-related disease, and cholestatic pruritus treatment.
• Label expansions for osilodrostat and mavacamten provided new therapeutic options for pediatric Cushing's syndrome and obstructive hypertrophic cardiomyopathy.
• Dupilumab's approval for chronic spontaneous urticaria offers a new treatment for inadequately controlled cases, based on LIBERTY-CUPID trial results.
• Gene therapy for recessive dystrophic epidermolysis bullosa and upadacitinib for giant cell arteritis mark significant therapeutic advancements.
• The FDA issued a Complete Response Letter for aflibercept, requesting additional data for extended dosing in neovascular age-related macular degeneration.