FDA PDUFA Calendar 2027: Drug Approval Dates

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 6 published FDA PDUFA decisions, including 5 NDAs and 1 BLA.

2027 FDA PDUFA dates: 6 published FDA PDUFA target action dates. Select a row to expand its full record.
Sponsor	Product	Type	Application	PDUFA date	Status
ImmunityBio	ANKTIVA + BCG	BLA	PENDING-provisional\|immunitybio\|anktivabcg\|bcgunresponsi	January 6, 2027	upcoming
Praxis Precision Medicines	ulixacaltamide	NDA	PENDING-provisional\|praxisprecisionmedicines\|ulixacaltam	January 29, 2027	upcoming
Shionogi	Fetroja (cefiderocol)	NDA	PENDING-provisional\|shionogi\|fetrojacefiderocol\|pediatri	February 23, 2027	upcoming
Immunome	varegacestat	NDA	PENDING-provisional\|immunome\|varegacestat\|adultswithdesm	April 28, 2027	upcoming
Axsome Therapeutics	AXS-12 (reboxetine)	NDA	PENDING-provisional\|axsometherapeutics\|axs12reboxetine\|c	May 1, 2027	upcoming
BridgeBio Pharma	encaleret	NDA	PENDING-provisional\|bridgebiopharma\|encaleret\|autosomald	May 8, 2027	upcoming

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, calendar views, 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.