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
| Ticker | Company | Drug / event | Date | Source |
|---|---|---|---|---|
| IRD | Opus Genetics, Inc. | PDUFA target action date | 2026-10-17 | Event source |
| VTRS | Viatris Inc. | PDUFA target action date | 2026-10-17 | Event source |
| IONS | IONIS PHARMACEUTICALS, INC. | PDUFA target action date | 2026-10-26 | Event source |
| INO | INOVIO PHARMACEUTICALS, INC. | PDUFA target action date | 2026-10-30 | Event source |
| AGIO | Agios Pharmaceuticals, Inc. | PDUFA target action date | 2026-11-01 | Event source |
| BTAI | BioXcel Therapeutics, Inc. | PDUFA target action date | 2026-11-14 | Event source |
| CYTK | CYTOKINETICS INC | PDUFA target action date | 2026-11-14 | Event source |
| SMMT | Summit Therapeutics Inc. | PDUFA target action date | 2026-11-14 | Event 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