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Home › Calendar › September 2026

September 2026 FDA PDUFA decisions

Updated ยทnext FDA decision on the calendar
PDUFA target dates for September 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← August 2026October 2026 →
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
IONS · 2026-09-22
Zilganersen (ION373)
MIRM · 2026-09-26
zilurgisertib
INCY · 2026-09-26
zilurgisertib
BFRI · 2026-09-28
Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series
PFE · 2026-09-30
Brepocitinib (VALOR)
PTGX · 2026-09-30
Rusfertide - (REVIVE)
ROIV · 2026-09-30
Brepocitinib - (VALOR)
TAK · 2026-09-30
Oveporexton (TAK-861-2001)
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).

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Every company listed above, with its full catalyst history, past FDA decisions and measured run-up into each one.
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