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.

July 2026 FDA PDUFA Calendar: Drug Approval Dates

FDA PDUFA dates in July 2026

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

Tracking 12 published FDA PDUFA decisions, including 7 NDAs and 5 BLAs.

FDA PDUFA dates in July 2026: 12 published FDA PDUFA target action dates. Select a row to expand its full record.
Sponsor	Product	Type	Application	PDUFA date	Status
Ascelia Pharma	Orviglance	NDA	PENDING-provisional\|asceliapharma\|orviglance\|liverimagin	July 3, 2026	overdue
Orca Bio	Orca-T	BLA	PENDING-provisional\|orcabio\|orcat\|hematologicmalignancie	July 6, 2026	decided
VERA THERAPEUTICS INC.	TRUTAKNA	BLA	BLA 761486 ORIG-1	July 7, 2026	decided
Daiichi Sankyo and AstraZeneca	ENHERTU	BLA	PENDING-provisional\|daiichisankyoandastrazeneca\|enhertu\|	July 7, 2026	decided
CORCEPT THERAP	LIFYORLI (COPACKAGED)	NDA	NDA 220641 ORIG-1	July 11, 2026	decided
CELCUITY	REVTORPYK	NDA	NDA 219908 ORIG-1	July 17, 2026	decided
SANOFI-AVENTIS U.S. LLC	SARCLISA ESCENA	BLA	BLA 761445 ORIG-1	July 23, 2026	decided
Elevar Therapeutics	rivoceranib + camrelizumab	NDA	PENDING-provisional\|elevartherapeutics\|rivoceranibcamrel	July 23, 2026	overdue
OTSUKA PHARMACEUTICAL CO LTD	SYMTRIYO	NDA	NDA 218145 ORIG-1	July 24, 2026	decided
MannKind	FUROSCIX ReadyFlow Autoinjector	NDA	PENDING-provisional\|mannkind\|furoscixreadyflowautoinject	July 26, 2026	decided
OUTLOOK THERAPEUTICS, INC.	LYTENAVA	BLA	BLA 761320 ORIG-1	July 29, 2026	decided
VIATRIS SPECIALTY	GWYN LO	NDA	NDA 219990 ORIG-1	July 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.

July 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

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