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.
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This FDA News Month in Review provides a round-up of regulatory decisions from April 2025.
Amgen reported dazodalibep met its primary endpoint in the phase 3 OASIZ-301 trial, improving ESSDAI score in moderate-to-severe systemic Sjögren's disease.