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2027 FDA PDUFA dates

Published PDUFA target action dates for NDAs, BLAs, ANDAs, and INDs scheduled in 2027, sourced from FDA primary records and updated daily.

Tracking 26 published FDA PDUFA decisions, including 19 NDAs and 7 BLAs.

2027 FDA PDUFA dates: 26 published FDA PDUFA target action dates. Select a row to expand its full record.
SponsorProductTypeApplicationPDUFA dateStatusAsk, copy and expand
ImmunityBioANKTIVA + BCGBLAPENDING-provisional|immunitybio|anktivabcg|bcgunresponsiupcoming
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Genentech (Roche)Enspryng (satralizumab)BLAPENDING-e1d6c2419b7dba3a0ffb7b2efb5d946dc347532aeb2b46a6upcoming
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Dyne Therapeuticszeleciment rostudirsen (DYNE-251)BLAPENDING-provisional|dynetherapeutics|zelecimentrostudirsupcoming
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InsmedARIKAYCE (amikacin liposome inhalation suspension)NDAPENDING-provisional|insmed|arikayceamikacinliposomeinhalupcoming
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Praxis Precision MedicinesulixacaltamideNDAPENDING-provisional|praxisprecisionmedicines|ulixacaltamupcoming
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Pharming GroupJoenja (leniolisib), lower pediatric dosesNDAPENDING-provisional|pharminggroup|joenjaleniolisiblowerpupcoming
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BridgeBio PharmainfigratinibNDAPENDING-provisional|bridgebiopharma|infigratinib|achondrupcoming
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Belite BiotinlarebantNDAPENDING-provisional|belitebio|tinlarebant|stargardtdiseaupcoming
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ShionogiFetroja (cefiderocol)NDAPENDING-provisional|shionogi|fetrojacefiderocol|pediatriupcoming
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Cullinan Therapeutics and Taiho PharmaceuticalzipalertinibNDAPENDING-provisional|cullinantherapeuticsandtaihopharmaceupcoming
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BioMarin PharmaceuticalVOXZOGO (vosoritide)NDAPENDING-provisional|biomarinpharmaceutical|voxzogovosoriupcoming
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Sarepta TherapeuticsAMONDYS 45 (casimersen)NDAPENDING-provisional|sareptatherapeutics|amondys45casimerupcoming
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Sarepta TherapeuticsVYONDYS 53 (golodirsen)NDAPENDING-provisional|sareptatherapeutics|vyondys53golodirupcoming
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ApnimedAD109 (aroxybutynin and atomoxetine)NDAPENDING-provisional|apnimed|ad109aroxybutyninandatomoxetupcoming
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Exelixiszanzalintinib + atezolizumabNDAPENDING-provisional|exelixis|zanzalintinibatezolizumab|pupcoming
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Intellia Therapeuticslonvoguran ziclumeran (lonvo-z)BLAPENDING-provisional|intelliatherapeutics|lonvoguranzicluupcoming
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PolarityBioSkinTEBLAPENDING-provisional|polaritybio|skinte|wagnergrade1diabeupcoming
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Inhibrx Biosciencesozekibart (INBRX-109)BLAPENDING-provisional|inhibrxbiosciences|ozekibartinbrx109upcoming
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Pharvarisdeucrictibant IRNDAPENDING-provisional|pharvaris|deucrictibantir|ondemandtrupcoming
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ImmunomevaregacestatNDAPENDING-provisional|immunome|varegacestat|adultswithdesmupcoming
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Axsome TherapeuticsAXS-12 (reboxetine)NDAPENDING-provisional|axsometherapeutics|axs12reboxetine|cupcoming
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BridgeBio PharmaencaleretNDAPENDING-provisional|bridgebiopharma|encaleret|autosomaldupcoming
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Bristol Myers Squibbmezigdomide + carfilzomib + dexamethasoneNDAPENDING-provisional|bristolmyerssquibb|mezigdomidecarfilupcoming
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Zenas BioPharmaobexelimabBLAPENDING-provisional|zenasbiopharma|obexelimab|immunoglobupcoming
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United TherapeuticsralinepagNDAPENDING-provisional|unitedtherapeutics|ralinepag|pulmonaupcoming
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Cogent BiosciencesbezuclastinibNDAPENDING-provisional|cogentbiosciences|bezuclastinib|advaupcoming
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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 2027: Drug Approval Dates & Deadlines

Track 2027 FDA review dates and approval decisions. Browse products, sponsors, application types, source-linked deadlines, and outcomes in the PDUFA calendar.

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How to use the 2027 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.

2027 PDUFA calendar FAQ

What is the 2027 FDA PDUFA calendar?

The 2027 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.