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2026 FDA PDUFA dates

Published PDUFA target action dates for NDAs, BLAs, ANDAs, and INDs scheduled in 2026, sourced from FDA primary records and updated daily.

Tracking 50 published FDA PDUFA decisions, including 27 NDAs and 23 BLAs.

2026 FDA PDUFA dates: 50 published FDA PDUFA target action dates. Select a row to expand its full record.
SponsorProductTypeApplicationPDUFA dateStatusExpand and copy
REGENERON PHARMACEUTICALSDUPIXENTBLABLA 761055 SUPPL-74decided
MSDIDVYNSONDANDA 216964 ORIG-1decided
PROVENTION BIO INCTZIELDBLABLA 761183 SUPPL-13decided
Axsome TherapeuticsAXS-05NDAPENDING-provisional|axsometherapeutics|axs05|agitationasdecided
ARGENX BVVYVGARTBLABLA 761195 SUPPL-16decided
Daiichi Sankyo and AstraZenecaENHERTU followed by THPBLAPENDING-provisional|daiichisankyoandastrazeneca|enhertufdecided
MANNKINDAFREZZABLABLA 022472 SUPPL-29decided
CingulateCTx-1301NDAPENDING-provisional|cingulate|ctx1301|attentiondeficithyoverdue
DAIICHI SANKYO INCDATROWAYBLABLA 761394 SUPPL-3decided
RIGEL PHARMSVEPPANUNDANDA 219835 ORIG-1decided
GLAXOSMITHKLINEUTEBZINDANDA 215960 ORIG-1decided
MerckKEYTRUDA + WELIREGBLAPENDING-provisional|merck|keytrudawelireg|adjuvanttreatmdecided
Achieve Life SciencescytisiniclineNDAPENDING-provisional|achievelifesciences|cytisinicline|nioverdue
ARCUTISZORYVENDANDA 215985 SUPPL-15decided
LantheusLNTH-2501 (Ga 68 edotreotide)NDAPENDING-provisional|lantheus|lnth2501ga68edotreotide|petoverdue
Unicycive Therapeuticsoxylanthanum carbonateNDAPENDING-provisional|unicycivetherapeutics|oxylanthanumcaoverdue
VIRIDIAN THERAPEUTICS INCLUMVOABLABLA 761530 ORIG-1decided
IONIS PHARMS INCTRYNGOLZA (AUTOINJECTOR)NDANDA 218614 SUPPL-4decided
Ascelia PharmaOrviglanceNDAPENDING-provisional|asceliapharma|orviglance|liverimaginoverdue
Orca BioOrca-TBLAPENDING-provisional|orcabio|orcat|hematologicmalignanciedecided
VERA THERAPEUTICS INC.TRUTAKNABLABLA 761486 ORIG-1decided
Daiichi Sankyo and AstraZenecaENHERTUBLAPENDING-provisional|daiichisankyoandastrazeneca|enhertu|decided
CORCEPT THERAPLIFYORLI (COPACKAGED)NDANDA 220641 ORIG-1decided
CELCUITYREVTORPYKNDANDA 219908 ORIG-1decided
SANOFI-AVENTIS U.S. LLCSARCLISA ESCENABLABLA 761445 ORIG-1decided
Elevar Therapeuticsrivoceranib + camrelizumabNDAPENDING-provisional|elevartherapeutics|rivoceranibcamreloverdue
OTSUKA PHARMACEUTICAL CO LTDSYMTRIYONDANDA 218145 ORIG-1decided
MannKindFUROSCIX ReadyFlow AutoinjectorNDAPENDING-provisional|mannkind|furoscixreadyflowautoinjectdecided
OUTLOOK THERAPEUTICS, INC.LYTENAVABLABLA 761320 ORIG-1decided
VIATRIS SPECIALTYGWYN LONDANDA 219990 ORIG-1decided
Replimune GroupRP1 (vusolimogene oderparepvec)BLAPENDING-provisional|replimunegroup|rp1vusolimogeneoderpadecided
ModernamRNA-1010BLAPENDING-provisional|moderna|mrna1010|seasonalinfluenzaprdecided
LantheusMK-6240NDAPENDING-provisional|lantheus|mk6240|petimagingagenttargeupcoming
Merck, Astellas, and PfizerKEYTRUDA + PADCEVBLAPENDING-provisional|merckastellasandpfizer|keytrudapadcedecided
Bristol Myers Squibbiberdomide + daratumumab/dexamethasoneNDAPENDING-provisional|bristolmyerssquibb|iberdomidedaratumupcoming
Capricor TherapeuticsderamiocelBLAPENDING-provisional|capricortherapeutics|deramiocel|duchupcoming
Ultragenyx PharmaceuticalDTX401BLAPENDING-provisional|ultragenyxpharmaceutical|dtx401|glycupcoming
EISAI INCLEQEMBI IQLIKBLABLA 761375 SUPPL-1decided
Jazz PharmaceuticalsZiiheraBLAPENDING-provisional|jazzpharmaceuticals|ziihera|firstlinupcoming
Gilead Sciencesbictegravir/lenacapavirNDAPENDING-provisional|gileadsciences|bictegravirlenacapaviupcoming
ITM Isotope Technologies Munich177Lu-edotreotideNDAPENDING-provisional|itmisotopetechnologiesmunich|177luedupcoming
PharmaEssentiaBESREMiBLAPENDING-provisional|pharmaessentia|besremi|essentialthroupcoming
AdvicenneSibnayalNDAPENDING-provisional|advicenne|sibnayal|distalrenaltubulaupcoming
Telix PharmaceuticalsTLX101-Px (Pixclara)NDAPENDING-provisional|telixpharmaceuticals|tlx101pxpixclarupcoming
NuvalentzidesamtinibNDAPENDING-provisional|nuvalent|zidesamtinib|ros1positivenoupcoming
Ultragenyx PharmaceuticalUX111BLAPENDING-provisional|ultragenyxpharmaceutical|ux111|sanfiupcoming
MerckWINREVAIRBLAPENDING-provisional|merck|winrevair|pulmonaryarterialhypupcoming
Ionis PharmaceuticalszilganersenNDAPENDING-provisional|ionispharmaceuticals|zilganersen|aleupcoming
Incyte Corporation / Mirum PharmaceuticalsZilurgisertibNDAPENDING-provisional|incytecorporationmirumpharmaceuticalupcoming
BiofronteraAmeluz-PDTNDAPENDING-provisional|biofrontera|ameluzpdt|superficialbasupcoming

Select any row to expand its full record. Use the calendar, timeline, status board, or table views above to filter, sort, and inspect source-linked details.

FDA PDUFA Calendar 2026: Drug Approval Dates & Deadlines

Track 2026 FDA PDUFA dates for NDA, BLA, ANDA, and IND decisions. Free drug approval tracker with source-linked deadlines, calendar views, and daily updates.

How to use the 2026 PDUFA calendar

Use this year-specific view to monitor FDA target action dates, compare review timing across sponsors and application types, and prepare portfolio reviews around the milestones that matter most.

Filter by application type to focus on NDA, BLA, ANDA, or IND records.
Switch to the timeline view to compare published target dates and observed decisions.
Use the table view when you need a compact source-linked working list.

2026 PDUFA calendar FAQ

What is the 2026 FDA PDUFA calendar?

The 2026 FDA PDUFA calendar tracks public target action dates and review milestones for drug and biologics applications where Assyro has source-linked records.

Which applications are included?

The calendar focuses on publicly available NDA and BLA review milestones and separates records with published target dates from records that do not yet have a public date.

How often is the PDUFA calendar updated?

Assyro refreshes the calendar from public FDA source data and shows the latest sync timestamp inside the tool when available.