NexVeris AI

PDUFA Calendar

Search upcoming FDA target action dates by ticker, company or drug and verify the underlying source record.

Data snapshot: 2026-10-14T11:47:58.610Z

TickerCompanyDrug / eventDateSource
IRDOpus Genetics, Inc.PDUFA target action date2026-10-17Event source
VTRSViatris Inc.PDUFA target action date2026-10-17Event source
IONSIONIS PHARMACEUTICALS, INC.PDUFA target action date2026-10-26Event source
INOINOVIO PHARMACEUTICALS, INC.PDUFA target action date2026-10-30Event source
AGIOAgios Pharmaceuticals, Inc.PDUFA target action date2026-11-01Event source
BTAIBioXcel Therapeutics, Inc.PDUFA target action date2026-11-14Event source
CYTKCYTOKINETICS INCPDUFA target action date2026-11-14Event source
SMMTSummit Therapeutics Inc.PDUFA target action date2026-11-14Event source

What is a PDUFA date?

A PDUFA date is a target for the FDA's review of a drug application under the Prescription Drug User Fee Act. It is not a guaranteed approval or a confirmed announcement time.

What should you verify?

Compare the target date, application, drug and indication with the latest company or FDA source. A review can be extended. An older calendar entry should not override a newer source announcement.

Sources: FDA PDUFA programme