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October 2026 FDA PDUFA decisions

Updated ยทnext 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
MRK · 2026-10-10
Ifinatamab deruxtecan (I-DXd)
VTRS · 2026-10-17
MR-141
PHAR · 2026-10-24
Leniolisib: APDS
GSK · 2026-10-26
Bepirovirsen - (B-Well)
INO · 2026-10-30
VGX-3100: Cervical Dysplasia
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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