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.

October 2026 FDA PDUFA Calendar: Drug Approval Dates

FDA PDUFA dates in October 2026

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

Tracking 8 published FDA PDUFA decisions, including 4 NDAs and 4 BLAs.

FDA PDUFA dates in October 2026: 8 published FDA PDUFA target action dates. Select a row to expand its full record.
Sponsor	Product	Type	Application	PDUFA date	Status
Merck and Eisai	WELIREG + LENVIMA	NDA	PENDING-provisional\|merckandeisai\|welireglenvima\|advance	October 4, 2026	upcoming
Daiichi Sankyo and Merck	ifinatamab deruxtecan	BLA	PENDING-provisional\|daiichisankyoandmerck\|ifinatamabderu	October 10, 2026	upcoming
Genentech / Roche	Enspryng (satralizumab)	BLA	PENDING-provisional\|genentechroche\|enspryngsatralizumab\|	October 15, 2026	upcoming
Opus Genetics and Viatris	phentolamine ophthalmic solution 0.75%	NDA	PENDING-provisional\|opusgeneticsandviatris\|phentolamineo	October 17, 2026	upcoming
Pharming Group N.V.	Joenja (leniolisib)	NDA	PENDING-provisional\|pharminggroupnv\|joenjaleniolisib\|act	October 24, 2026	upcoming
GSK	bepirovirsen	NDA	PENDING-provisional\|gsk\|bepirovirsen\|chronichepatitisb\|2	October 26, 2026	upcoming
Sun Pharmaceutical Industries	ILUMYA (tildrakizumab-asmn)	BLA	PENDING-provisional\|sunpharmaceuticalindustries\|ilumyati	October 29, 2026	upcoming
INOVIO Pharmaceuticals	INO-3107	BLA	PENDING-provisional\|inoviopharmaceuticals\|ino3107\|recurr	October 30, 2026	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.

October 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

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