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Upcoming Rare Disease FDA decisions & readouts
Updated ยทnext FDA decision on the calendar PDUFA target dates and trial readouts in rare disease, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
PDUFA decisions (3)
Trial readouts (8)
Every upcoming FDA decision date, all therapeutic areas, on the 2026 PDUFA calendar · all conditions
We don't show an approval percentage for these rare disease catalysts:
here's why.