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September 2026 FDA PDUFA decisions

PDUFA target dates for September 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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4 PDUFA dates
TLX · 2026-09-11
177Lu-TLX591 — Metastatic Castration-resistant Prostate Cancer
NUVL · 2026-09-18
Neladalkib — Non-small Cell Lung Cancer
RARE · 2026-09-19
UX111
MIRM · 2026-09-26
zilurgisertib
Looking for an approval probability for these? We deliberately don't publish one — here's why, and what we show instead (verified history + base rates).