MRK
Welireg (belzutifan) + Keytruda (pembrolizumab)
FDA PDUFA Target Action Date · Merck & Co., Inc.
Friday, June 19, 2026
29 days ago
approved Drug Information
- Application Type
- sNDA + sBLA
- FDA Designations
- Priority Review
- Indication
- Adjuvant clear cell renal cell carcinoma (ccRCC) at increased risk of recurrence
- Approved As
- IDVYNSO →
Filing Details
- Company
- Merck & Co., Inc. →
- Stock Ticker
- MRK
- SEC CIK
- 0000310158
- 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
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue