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Home › Calendar › April 2027

April 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 April 2027, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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6 PDUFA dates
HRMY · 2027-04-01
Pitolisant GR (gastro-resistant formulation) - NDA: CNS/Neurology
INBX · 2027-04-14
Ozekibart (INBRX-109): conventional chondrosarcoma
JAZZ · 2027-04-16
Cannabidiol oral capsule formulation (NDA): CNS/Neurology
MRK · 2027-04-22
IDVYNSO - treatment-naive HIV-1 (P053) and 96-week data (sNDAs): Infectious Disease
PHVS · 2027-04-23
Deucrictibant IR - (RAPIDe-3)
IMNM · 2027-04-28
Varegacestat - desmoid tumors (RINGSIDE): Oncology
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.
HRMYIMNMINBXJAZZMRKPHVS