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January 2027 FDA PDUFA decisions

Updated ยทnext FDA decision on the calendar
PDUFA target dates for January 2027, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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1 PDUFA dates
NUVB · 2027-01-04
IBTROZI (taletrectinib) sNDA
IBRX · 2027-01-06
ANKTIVA (N-803) + BCG
PRAX · 2027-01-29
ulixacaltamide
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.
IBRXNUVBPRAX