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Home › Calendar › January 2027

January 2027 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 January 2027, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← December 2026February 2027 →
7 PDUFA dates
NUVB · 2027-01-04 ✓
Approved: IBTROZI (taletrectinib) sNDA
IBRX · 2027-01-06 ✓
Approved: ANKTIVA (N-803) + BCG
RHHBY · 2027-01-10
Enspryng (satralizumab) - MOGAD (METEOROID): Neurology
DYN · 2027-01-21
Z-rostudirsen - Duchenne muscular dystrophy, exon 51: Rare Disease
INSM · 2027-01-28
ARIKAYCE (amikacin liposome inhalation suspension) - MAC lung disease (sNDA): Infectious Disease
PRAX · 2027-01-29
ulixacaltamide
PHAR · 2027-01-30
Joenja (leniolisib) lower doses - APDS, ages 4+ from 13 kg (sNDA): Immunology
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.
DYNIBRXINSMNUVBPHARPRAXRHHBY