pdufa.bio
CalendarDecisionsReadoutsPatents
Drug IndexStocksScreenerConferencesAdvisory Committees
StudiesRun-up by YearLearnGlossaryMethodologyAPIAccount
Pro
Home › Calendar › September 2026

September 2026 FDA PDUFA decisions

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET
PDUFA target dates for September 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← August 2026October 2026 →
15 PDUFA dates
TLX · 2026-09-11 ✓
Approved: TLX101-Px
NUVL · 2026-09-18 ✓
Approved: Zidesamtinib (NVL-520) - (ARROS-1)
LLY · 2026-09-18 ✓
Approved: Inluriyo (imlunestrant) + Verzenio (abemaciclib) - (EMBER-3): Oncology (FDA action date; no goal date on record)
RARE · 2026-09-19 ✓
Approved: UX111
MRK · 2026-09-21 ✓
Approved: WINREVAIR (sotatercept-csrk) - (HYPERION)
IONS · 2026-09-22 ✓
Approved: Zilganersen (ION373)
RHHBY · 2026-09-25 ✓
Approved: Gazyva (obinutuzumab) - idiopathic nephrotic syndrome: Nephrology (FDA action date; no goal date on record)
MIRM · 2026-09-26 ✓
Approved: zilurgisertib
INCY · 2026-09-26 ✓
Approved: Zilurgisertib (Mirum holds the NDA; Incyte licensed it out): FOP
BFRI · 2026-09-28 ✓
Approved: Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series
PFE · Q3 2026 ✓
Approved: Brepocitinib (VALOR)
PTGX · Q3 2026 ✓
Approved: Rusfertide - (REVIVE)
ROIV · Q3 2026 ✓
Approved: Brepocitinib - (VALOR)
TAK · Q3 2026 ✓
Approved: Oveporexton (TAK-861-2001)
SRRK · 2026-09-30 ✓
Approved: Apitegromab - (SAPPHIRE): CNS/Neurology
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).

Companies on this page

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