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.

FDA PDUFA dates in September 2026

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

Tracking 12 published FDA PDUFA decisions, including 9 NDAs and 3 BLAs.

FDA PDUFA dates in September 2026: 12 published FDA PDUFA target action dates. Select a row to expand its full record.
Sponsor	Product	Type	Application	PDUFA date	Status	Ask, copy and expand
Advicenne	Sibnayal	NDA	PENDING-provisional\|advicenne\|sibnayal\|distalrenaltubula	September 3, 2026	decided	Ask AI
TELIX PHARMACEUTICALS US INC	PIXCLARA	NDA	NDA 218592 ORIG-1	September 11, 2026	decided	Ask AI
NUVALENT INC	JIDEYTRO	NDA	NDA 220185 ORIG-1	September 18, 2026	decided	Ask AI
Ultragenyx Pharmaceutical	UX111	BLA	PENDING-provisional\|ultragenyxpharmaceutical\|ux111\|sanfi	September 19, 2026	decided	Ask AI
Merck	WINREVAIR	BLA	BLA 761363 SUPPL-12	September 21, 2026	decided	Ask AI
IONIS PHARMS INC	ZANVASTRO	NDA	NDA 220210 ORIG-1	September 22, 2026	decided	Ask AI
Incyte Corporation / Mirum Pharmaceuticals	Zilurgisertib	NDA	NDA 221198 ORIG-1	September 26, 2026	decided	Ask AI
Elevar Therapeutics	lirafugratinib	NDA	NDA 220425 ORIG-1	September 27, 2026	decided	Ask AI
BIOFRONTERA	AMELUZ	NDA	NDA 208081 SUPPL-40	September 28, 2026	decided	Ask AI
Egetis Therapeutics	Emcitate (tiratricol)	NDA	NDA 220963 ORIG-1	September 28, 2026	decided	Ask AI
SCHOLAR ROCK INC	ISEMBYLD	BLA	BLA 761463 ORIG-1	September 30, 2026	decided	Ask AI
Bristol Myers Squibb	CAMZYOS (mavacamten)	NDA	NDA 214998 SUPPL-13	September 30, 2026	decided	Ask AI

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.

September 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

Track September 2026 FDA review dates and drug approval decisions. Browse products, sponsors, application types, source-linked deadlines, and reported outcomes.

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