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2027 FDA PDUFA dates

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET
pdufa.bio lists 35 FDA PDUFA goal dates already set for 2027, each taken from the sponsor's own SEC filing or press release: 5 in January, 10 in February, 6 in March, 6 in April, 6 in May, 2 in June. Dates move when the FDA extends a review; every row links the event page that records the source and any change.
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35 PDUFA dates

January 2027 5 dates

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

February 2027 10 dates

AGIO · 2027-02-01
Mitapivat (PYRUKYND) goal date moved from Nov 1, 2026
GILD · 2027-02-02
Yeztugo (lenacapavir) once-weekly oral
BBIO · 2027-02-04
Oral infigratinib - achondroplasia in children (PROPEL 3): Rare Disease
RHHBY · 2027-02-09
Lunsumio VELO (mosunetuzumab) + Polivy - relapsed/refractory LBCL (SUNMO): Oncology
BLTE · 2027-02-12
Tinlarebant - Stargardt disease type 1: Ophthalmology
ARQT · 2027-02-23
ZORYVE (roflumilast) cream 0.05%
CGEM · 2027-02-27
Zipalertinib (CLN-081): relapsed EGFR exon 20 insertion NSCLC
APMD · 2027-02-28
AD109 (Oxnimbi): CNS/Neurology
BMRN · 2027-02-28
VOXZOGO (vosoritide): Rare Disease
PVLA · 2027-02-28
QTORIN rapamycin - microcystic lymphatic malformations (SELVA): Rare Disease

March 2027 6 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

April 2027 6 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

May 2027 6 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

June 2027 2 dates

URGN · 2027-06-14
UGN-103 (mitomycin): Oncology
MRK · 2027-06-15
Sacituzumab tirumotecan (sac-TMT) - endometrial cancer (TroFuse-005): 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.
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