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 August 2026

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

Tracking 11 published FDA PDUFA decisions, including 4 NDAs and 7 BLAs.

FDA PDUFA dates in August 2026: 11 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
Replimune Group	RP1 (vusolimogene oderparepvec)	BLA	PENDING-provisional\|replimunegroup\|rp1vusolimogeneoderpa	August 2, 2026	decided	Ask AI
Moderna	mRNA-1010	BLA	PENDING-provisional\|moderna\|mrna1010\|seasonalinfluenzapr	August 5, 2026	decided	Ask AI
CERVEAU LANTHEUS	TAUKLARIFY	NDA	NDA 220496 ORIG-1	August 13, 2026	decided	Ask AI
BRISTOL MYERS SQUIBB	ZENBEXUS	NDA	NDA 221075 ORIG-1	August 17, 2026	decided	Ask AI
Merck, Astellas, and Pfizer	KEYTRUDA + PADCEV	BLA	PENDING-provisional\|merckastellasandpfizer\|keytrudapadce	August 17, 2026	decided	Ask AI
Ultragenyx Pharmaceutical	DTX401	BLA	PENDING-provisional\|ultragenyxpharmaceutical\|dtx401\|glyc	August 23, 2026	decided	Ask AI
EISAI INC	LEQEMBI IQLIK	BLA	BLA 761375 SUPPL-1	August 24, 2026	decided	Ask AI
JAZZ PHARMS	ZIIHERA	BLA	BLA 761416 SUPPL-2	August 25, 2026	decided	Ask AI
GILEAD SCIENCES INC	BIXLENVO	NDA	NDA 221104 ORIG-1	August 27, 2026	decided	Ask AI
ITM Isotope Technologies Munich	177Lu-edotreotide	NDA	PENDING-provisional\|itmisotopetechnologiesmunich\|177lued	August 28, 2026	decided	Ask AI
PHARMAESSENTIA CORP	BESREMI	BLA	BLA 761166 SUPPL-13	August 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.

August 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

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

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