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Home › Calendar › October 2026

October 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 October 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← September 2026November 2026 →
10 PDUFA dates
LLY · 2026-10-02 ✓
Approved: Jaypirca (pirtobrutinib) - previously untreated CLL/SLL: Oncology (FDA action date; no goal date on record)
NVS · 2026-10-06 ✓
Approved: Rhapsido (remibrutinib): Immunology (FDA action date; no goal date on record)
RHHBY · 2026-10-09 ✓
Approved: Tecentriq (atezolizumab) adjuvant - (stage III colon)
MRK · 2026-10-10 withdrawn
Withdrawn Sep 25, 2026: Ifinatamab deruxtecan (I-DXd), no FDA decision
RHHBY · 2026-10-15 ✓
Approved: Enspryng (satralizumab) - (thyroid eye disease)
VTRS · 2026-10-17 ✓
Approved: MR-141
IRD · 2026-10-17 ✓
Approved: Phentolamine ophthalmic solution 0.75%: Ophthalmology
PHAR · 2026-10-24 ✓
Approved: Leniolisib: APDS
GSK · 2026-10-26 ✓
Approved: Bepirovirsen - (B-Well)
INO · 2026-10-30 ✓
Approved: INO-3107 DNA immunotherapy
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.
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