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Home › Calendar › October 2026

October 2026 FDA PDUFA decisions

Updated ·next FDA decision on the calendar
PDUFA target dates for October 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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3 PDUFA dates
RHHBY · 2026-10-09
Tecentriq (atezolizumab) adjuvant - (stage III colon)
MRK · 2026-10-10
Ifinatamab deruxtecan (I-DXd)
RHHBY · 2026-10-15
Enspryng (satralizumab) - (thyroid eye disease)
VTRS · 2026-10-17
MR-141
IRD · 2026-10-17
Phentolamine ophthalmic solution 0.75%: Ophthalmology
PHAR · 2026-10-24 ✓
Approved: Leniolisib: APDS
GSK · 2026-10-26
Bepirovirsen - (B-Well)
INO · 2026-10-30
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).

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