Skip to content
Assyro AI

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 22 published FDA PDUFA decisions, including 15 NDAs and 7 BLAs.

2027 FDA PDUFA dates: 22 published FDA PDUFA target action dates. Select a row to expand its full record.
SponsorProductTypeApplicationPDUFA dateStatusExpand and copy
ImmunityBioANKTIVA + BCGBLAPENDING-provisional|immunitybio|anktivabcg|bcgunresponsiupcoming
Genentech (Roche)Enspryng (satralizumab)BLAPENDING-e1d6c2419b7dba3a0ffb7b2efb5d946dc347532aeb2b46a6upcoming
Dyne Therapeuticszeleciment rostudirsen (DYNE-251)BLAPENDING-provisional|dynetherapeutics|zelecimentrostudirsupcoming
InsmedARIKAYCE (amikacin liposome inhalation suspension)NDAPENDING-provisional|insmed|arikayceamikacinliposomeinhalupcoming
Praxis Precision MedicinesulixacaltamideNDAPENDING-provisional|praxisprecisionmedicines|ulixacaltamupcoming
Belite BiotinlarebantNDAPENDING-provisional|belitebio|tinlarebant|stargardtdiseaupcoming
ShionogiFetroja (cefiderocol)NDAPENDING-provisional|shionogi|fetrojacefiderocol|pediatriupcoming
Sarepta TherapeuticsAMONDYS 45 (casimersen)NDAPENDING-provisional|sareptatherapeutics|amondys45casimerupcoming
Sarepta TherapeuticsVYONDYS 53 (golodirsen)NDAPENDING-provisional|sareptatherapeutics|vyondys53golodirupcoming
BioMarin PharmaceuticalVOXZOGO (vosoritide)NDAPENDING-provisional|biomarinpharmaceutical|voxzogovosoriupcoming
Exelixiszanzalintinib + atezolizumabNDAPENDING-provisional|exelixis|zanzalintinibatezolizumab|pupcoming
Intellia Therapeuticslonvoguran ziclumeran (lonvo-z)BLAPENDING-provisional|intelliatherapeutics|lonvoguranzicluupcoming
PolarityBioSkinTEBLAPENDING-provisional|polaritybio|skinte|wagnergrade1diabeupcoming
Inhibrx Biosciencesozekibart (INBRX-109)BLAPENDING-provisional|inhibrxbiosciences|ozekibartinbrx109upcoming
Pharvarisdeucrictibant IRNDAPENDING-provisional|pharvaris|deucrictibantir|ondemandtrupcoming
ImmunomevaregacestatNDAPENDING-provisional|immunome|varegacestat|adultswithdesmupcoming
Axsome TherapeuticsAXS-12 (reboxetine)NDAPENDING-provisional|axsometherapeutics|axs12reboxetine|cupcoming
BridgeBio PharmaencaleretNDAPENDING-provisional|bridgebiopharma|encaleret|autosomaldupcoming
Bristol Myers Squibbmezigdomide + carfilzomib + dexamethasoneNDAPENDING-provisional|bristolmyerssquibb|mezigdomidecarfilupcoming
Zenas BioPharmaobexelimabBLAPENDING-provisional|zenasbiopharma|obexelimab|immunoglobupcoming
United TherapeuticsralinepagNDAPENDING-provisional|unitedtherapeutics|ralinepag|pulmonaupcoming
Cogent BiosciencesbezuclastinibNDAPENDING-provisional|cogentbiosciences|bezuclastinib|advaupcoming

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

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.