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Home › Calendar › March 2027

March 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 March 2027, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← February 2027April 2027 →
6 PDUFA dates
EXEL · 2027-03-03
Zanzalintinib (XL092) + atezolizumab goal date moved from Dec 3, 2026
NTLA · 2027-03-10
Lonvoguran ziclumeran (lonvo-z): Rare Disease
BMY · 2027-03-11
Reblozyl (luspatercept) with a JAK inhibitor - myelofibrosis-associated anemia (INDEPENDENCE): Hematology
AQST · 2027-03-16
Anaphylm (dibutepinephrine) sublingual film - NDA resubmission: Immunology
MRK · 2027-03-22
ENFLONSIA (clesrovimab) - second RSV season (SMART): Infectious Disease
ETON · 2027-03-29
LIBERVANT (diazepam) buccal film - ages 6 to 11 (Type 9 NDA): CNS/Neurology
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.
AQSTBMYETONEXELMRKNTLA