Question 1

What is a PDUFA date?

Accepted Answer

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.

Question 2

How often is the calendar updated?

Accepted Answer

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.

Question 3

Where does the data come from?

Accepted Answer

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.

Question 4

Is the PDUFA calendar tool free?

Accepted Answer

Yes. The Assyro PDUFA calendar is free to use, with no account required. Calendar, Gantt timeline, status board, and table views are all included.

Question 5

Which application types are tracked?

Accepted Answer

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.

Question 6

Does the tool cover EMA or Health Canada review dates?

Accepted Answer

No. Today the calendar covers FDA review deadlines only. Coverage is limited to U.S. PDUFA dates and FDA decision dates.

Sponsor	Product	Type	Application	PDUFA date	Status
GSK and Spero Therapeutics	tebipenem HBr	NDA	PENDING-provisional\|gskandsperotherapeutics\|tebipenemhbr	June 18, 2026	upcoming
Merck	KEYTRUDA + WELIREG	BLA	PENDING-provisional\|merck\|keytrudawelireg\|adjuvanttreatm	June 19, 2026	upcoming
Achieve Life Sciences	cytisinicline	NDA	PENDING-provisional\|achievelifesciences\|cytisinicline\|ni	June 20, 2026	upcoming
Arcutis Biotherapeutics	ZORYVE cream 0.3%	NDA	PENDING-provisional\|arcutisbiotherapeutics\|zoryvecream03	June 29, 2026	upcoming
Lantheus	LNTH-2501 (Ga 68 edotreotide)	NDA	PENDING-provisional\|lantheus\|lnth2501ga68edotreotide\|pet	June 29, 2026	upcoming
Unicycive Therapeutics	oxylanthanum carbonate	NDA	PENDING-provisional\|unicycivetherapeutics\|oxylanthanumca	June 29, 2026	upcoming
Ionis Pharmaceuticals	olezarsen	NDA	PENDING-provisional\|ionispharmaceuticals\|olezarsen\|sever	June 30, 2026	upcoming
Viridian Therapeutics	veligrotug	BLA	PENDING-provisional\|viridiantherapeutics\|veligrotug\|thyr	June 30, 2026	upcoming
Ascelia Pharma	Orviglance	NDA	PENDING-provisional\|asceliapharma\|orviglance\|liverimagin	July 3, 2026	upcoming
Orca Bio	Orca-T	BLA	PENDING-provisional\|orcabio\|orcat\|hematologicmalignancie	July 6, 2026	upcoming
Vera Therapeutics	atacicept	BLA	PENDING-provisional\|veratherapeutics\|atacicept\|iganephro	July 7, 2026	upcoming
Daiichi Sankyo and AstraZeneca	ENHERTU	BLA	PENDING-provisional\|daiichisankyoandastrazeneca\|enhertu\|	July 7, 2026	upcoming
Corcept Therapeutics	relacorilant + nab-paclitaxel	NDA	PENDING-provisional\|corcepttherapeutics\|relacorilantnabp	July 11, 2026	upcoming
Celcuity	gedatolisib	NDA	PENDING-provisional\|celcuity\|gedatolisib\|hrpositiveher2n	July 17, 2026	upcoming
Elevar Therapeutics	rivoceranib + camrelizumab	NDA	PENDING-provisional\|elevartherapeutics\|rivoceranibcamrel	July 23, 2026	upcoming
Sanofi	Sarclisa SC	BLA	PENDING-provisional\|sanofi\|sarclisasc\|multiplemyeloma\|20	July 23, 2026	upcoming
Otsuka Pharmaceutical	centanafadine	NDA	PENDING-provisional\|otsukapharmaceutical\|centanafadine\|a	July 24, 2026	upcoming
MannKind	FUROSCIX ReadyFlow Autoinjector	NDA	PENDING-provisional\|mannkind\|furoscixreadyflowautoinject	July 26, 2026	upcoming
Viatris	low-dose estrogen weekly patch	NDA	PENDING-provisional\|viatris\|lowdoseestrogenweeklypatch\|c	July 30, 2026	upcoming
Moderna	mRNA-1010	BLA	PENDING-provisional\|moderna\|mrna1010\|seasonalinfluenzapr	August 5, 2026	upcoming
Lantheus	MK-6240	NDA	PENDING-provisional\|lantheus\|mk6240\|petimagingagenttarge	August 13, 2026	upcoming
Bristol Myers Squibb	iberdomide + daratumumab/dexamethasone	NDA	PENDING-provisional\|bristolmyerssquibb\|iberdomidedaratum	August 17, 2026	upcoming
Merck, Astellas, and Pfizer	KEYTRUDA + PADCEV	BLA	PENDING-provisional\|merckastellasandpfizer\|keytrudapadce	August 17, 2026	upcoming
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 and Biogen	LEQEMBI IQLIK	BLA	PENDING-provisional\|eisaiandbiogen\|leqembiiqlik\|subcutan	August 24, 2026	upcoming
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
Advicenne	Sibnayal	NDA	PENDING-provisional\|advicenne\|sibnayal\|distalrenaltubula	September 3, 2026	upcoming

Upcoming FDA PDUFA dates (next 90 days)

FDA PDUFA Calendar: Drug Approval Dates & Deadlines