What is a PDUFA date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA target action date for completing review of a New Drug Application (NDA) or Biologics License Application (BLA). The FDA commits to issuing an approval, complete response, or other regulatory decision by this date.

How often is the calendar updated?

The Assyro PDUFA calendar syncs daily from FDA primary sources, including approval announcements, FDA dataset feeds, and sponsor disclosures. The "Synced" indicator at the top of the page shows when the records were last refreshed.

Where does the data come from?

Every event is source-linked. Sources include FDA approval pages, FDA datasets, FDA labels, and sponsor press releases. Click any event to view the underlying source URLs and the source confidence score.

Is the PDUFA calendar tool free?

Yes. The Assyro PDUFA calendar is free to use, with no account required. Calendar, Gantt timeline, status board, and table views are all included.

Which application types are tracked?

NDAs (New Drug Applications), BLAs (Biologics License Applications), ANDAs (Abbreviated New Drug Applications), and INDs (Investigational New Drug Applications) are tracked. Filter by application type using the Application type dropdown.

Does the tool cover EMA or Health Canada review dates?

No. Today the calendar covers FDA review deadlines only. Coverage is limited to U.S. PDUFA dates and FDA decision dates.

May 2026 FDA PDUFA Calendar: Drug Approval Dates

FDA PDUFA dates in May 2026

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

Tracking 4 published FDA PDUFA decisions, including 1 NDA and 3 BLAs.

FDA PDUFA dates in May 2026: 4 published FDA PDUFA target action dates. Select a row to expand its full record.
Sponsor	Product	Type	Application	PDUFA date	Status
ARGENX BV	VYVGART	BLA	BLA 761195 SUPPL-16	May 10, 2026	decided
Daiichi Sankyo and AstraZeneca	ENHERTU followed by THP	BLA	PENDING-provisional\|daiichisankyoandastrazeneca\|enhertuf	May 18, 2026	decided
MANNKIND	AFREZZA	BLA	BLA 022472 SUPPL-29	May 29, 2026	decided
Cingulate	CTx-1301	NDA	PENDING-provisional\|cingulate\|ctx1301\|attentiondeficithy	May 31, 2026	overdue

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.

May 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

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