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Upcoming Rare Disease FDA decisions & readouts
Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET 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 (9)
Trial readouts (9)
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.