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.

June 2026 FDA PDUFA Calendar: Drug Approval Dates

FDA PDUFA dates in June 2026

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

Tracking 10 published FDA PDUFA decisions, including 7 NDAs and 3 BLAs.

FDA PDUFA dates in June 2026: 10 published FDA PDUFA target action dates. Select a row to expand its full record.
Sponsor	Product	Type	Application	PDUFA date	Status
DAIICHI SANKYO INC	DATROWAY	BLA	BLA 761394 SUPPL-3	June 2, 2026	decided
RIGEL PHARMS	VEPPANU	NDA	NDA 219835 ORIG-1	June 5, 2026	decided
GLAXOSMITHKLINE	UTEBZI	NDA	NDA 215960 ORIG-1	June 18, 2026	decided
Merck	KEYTRUDA + WELIREG	BLA	PENDING-provisional\|merck\|keytrudawelireg\|adjuvanttreatm	June 19, 2026	decided
Achieve Life Sciences	cytisinicline	NDA	PENDING-provisional\|achievelifesciences\|cytisinicline\|ni	June 20, 2026	overdue
ARCUTIS	ZORYVE	NDA	NDA 215985 SUPPL-15	June 29, 2026	decided
Lantheus	LNTH-2501 (Ga 68 edotreotide)	NDA	PENDING-provisional\|lantheus\|lnth2501ga68edotreotide\|pet	June 29, 2026	overdue
Unicycive Therapeutics	oxylanthanum carbonate	NDA	PENDING-provisional\|unicycivetherapeutics\|oxylanthanumca	June 29, 2026	overdue
VIRIDIAN THERAPEUTICS INC	LUMVOA	BLA	BLA 761530 ORIG-1	June 30, 2026	decided
IONIS PHARMS INC	TRYNGOLZA (AUTOINJECTOR)	NDA	NDA 218614 SUPPL-4	June 30, 2026	decided

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.

June 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

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