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 November 2026

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

Tracking 15 published FDA PDUFA decisions, including 11 NDAs and 4 BLAs.

FDA PDUFA dates in November 2026: 15 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
Agios Pharmaceuticals	mitapivat	NDA	PENDING-provisional\|agiospharmaceuticals\|mitapivat\|sickl	November 1, 2026	overdue	Ask AI
Cytokinetics	MYQORZO (aficamten)	NDA	PENDING-provisional\|cytokinetics\|myqorzoaficamten\|obstru	November 14, 2026	upcoming	Ask AI
BioXcel Therapeutics	IGALMI	NDA	PENDING-provisional\|bioxceltherapeutics\|igalmi\|acutetrea	November 14, 2026	upcoming	Ask AI
Summit Therapeutics	ivonescimab + chemotherapy	BLA	PENDING-provisional\|summittherapeutics\|ivonescimabchemot	November 14, 2026	upcoming	Ask AI
Beren Therapeutics	adrabetadex	NDA	PENDING-provisional\|berentherapeutics\|adrabetadex\|infant	November 17, 2026	upcoming	Ask AI
Savara	molgramostim	BLA	PENDING-provisional\|savara\|molgramostim\|autoimmunepulmon	November 22, 2026	upcoming	Ask AI
Capricor Therapeutics	deramiocel	BLA	PENDING-provisional\|capricortherapeutics\|deramiocel\|duch	November 22, 2026	upcoming	Ask AI
Sanofi	venglustat	NDA	PENDING-provisional\|sanofi\|venglustat\|type3gaucherdiseas	November 25, 2026	upcoming	Ask AI
BridgeBio Pharma	BBP-418	NDA	PENDING-provisional\|bridgebiopharma\|bbp418\|limbgirdlemus	November 27, 2026	upcoming	Ask AI
Zydus Therapeutics	saroglitazar	NDA	PENDING-provisional\|zydustherapeutics\|saroglitazar\|prima	November 27, 2026	upcoming	Ask AI
Nuvalent	neladalkib	NDA	PENDING-provisional\|nuvalent\|neladalkib\|tkipretreatedadv	November 27, 2026	upcoming	Ask AI
PolyPid	D-PLEX100	NDA	PENDING-provisional\|polypid\|dplex100\|preventionofsurgica	November 28, 2026	upcoming	Ask AI
Vertex Pharmaceuticals	povetacicept	BLA	PENDING-provisional\|vertexpharmaceuticals\|povetacicept\|a	November 30, 2026	upcoming	Ask AI
Genentech (Roche)	giredestrant	NDA	PENDING-provisional\|genentechroche\|giredestrant\|adjuvant	November 30, 2026	upcoming	Ask AI
Cogent Biosciences	bezuclastinib + sunitinib	NDA	PENDING-provisional\|cogentbiosciences\|bezuclastinibsunit	November 30, 2026	upcoming	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.

November 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines

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

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