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May 2027 FDA PDUFA decisions

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET
PDUFA target dates for May 2027, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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6 PDUFA dates
AXSM · 2027-05-01
AXS-12
QURE · 2027-05-01
Ifezuntirgene inilparvovec (AMT-130) - Huntington's disease: Neurology
BBIO · 2027-05-08
Encaleret
BMY · 2027-05-13
Mezigdomide + carfilzomib + dexamethasone - RRMM (SUCCESSOR-2): Hematology
ZBIO · 2027-05-27
Obexelimab - IgG4-related disease: Immunology
BMRN · 2027-05-30
VOXZOGO (vosoritide) - hypochondroplasia (sNDA): Rare Disease
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.
AXSMBBIOBMRNBMYQUREZBIO