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.

August 2026 FDA PDUFA Calendar: Drug Approval 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 12 published FDA PDUFA decisions, including 4 NDAs and 8 BLAs.

FDA PDUFA dates in August 2026: 12 published FDA PDUFA target action dates. Select a row to expand its full record.
Sponsor	Product	Type	Application	PDUFA date	Status
Replimune Group	RP1 (vusolimogene oderparepvec)	BLA	PENDING-provisional\|replimunegroup\|rp1vusolimogeneoderpa	August 2, 2026	decided
Moderna	mRNA-1010	BLA	PENDING-provisional\|moderna\|mrna1010\|seasonalinfluenzapr	August 5, 2026	decided
Lantheus	MK-6240	NDA	PENDING-provisional\|lantheus\|mk6240\|petimagingagenttarge	August 13, 2026	overdue
Merck, Astellas, and Pfizer	KEYTRUDA + PADCEV	BLA	PENDING-provisional\|merckastellasandpfizer\|keytrudapadce	August 17, 2026	decided
Bristol Myers Squibb	iberdomide + daratumumab/dexamethasone	NDA	PENDING-provisional\|bristolmyerssquibb\|iberdomidedaratum	August 17, 2026	overdue
Capricor Therapeutics	deramiocel	BLA	PENDING-provisional\|capricortherapeutics\|deramiocel\|duch	August 22, 2026	upcoming
Ultragenyx Pharmaceutical	DTX401	BLA	PENDING-provisional\|ultragenyxpharmaceutical\|dtx401\|glyc	August 23, 2026	upcoming
EISAI INC	LEQEMBI IQLIK	BLA	BLA 761375 SUPPL-1	August 24, 2026	decided
Jazz Pharmaceuticals	Ziihera	BLA	PENDING-provisional\|jazzpharmaceuticals\|ziihera\|firstlin	August 25, 2026	upcoming
Gilead Sciences	bictegravir/lenacapavir	NDA	PENDING-provisional\|gileadsciences\|bictegravirlenacapavi	August 27, 2026	upcoming
ITM Isotope Technologies Munich	177Lu-edotreotide	NDA	PENDING-provisional\|itmisotopetechnologiesmunich\|177lued	August 28, 2026	upcoming
PharmaEssentia	BESREMi	BLA	PENDING-provisional\|pharmaessentia\|besremi\|essentialthro	August 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.

August 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

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