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 2027 FDA PDUFA Calendar: Drug Approval Dates

FDA PDUFA dates in May 2027

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

Tracking 2 published FDA PDUFA decisions, including 2 NDAs.

FDA PDUFA dates in May 2027: 2 published FDA PDUFA target action dates. Select a row to expand its full record.
Sponsor	Product	Type	Application	PDUFA date	Status	Expand and copy
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.

May 2027 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

Track May 2027 FDA PDUFA dates for NDA, BLA, ANDA, and IND decisions. Free drug approval tracker with source-linked deadlines, calendar views, and daily updates.