Thursday, July 30, 2026
12 days away
Drug Information
- Drug Name
- Pivekimab sunirine (PVEK) (CT.gov)
- Application Type
- BLA
- FDA Designations
- Breakthrough
- Indication
- Blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Filing Details
- Company
- AbbVie Inc. →
- Stock Ticker
- ABBV
- SEC CIK
- 0001551152
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Explore AbbVie Inc.
View AbbVie Inc.'s full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue