MRK

Merck & Co., Inc.

FDA PDUFA Target Action Date

Sunday, October 4, 2026

131 days away

Drug Information

Drug Name: Welireg (belzutifan) + Lenvima (lenvatinib) (CT.gov)
Application Type: sNDA
Indication: Previously treated advanced ccRCC post-PD-1/PD-L1 therapy

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

Explore Merck & Co., Inc.

View Merck & Co., Inc.'s full pipeline, approved drugs, and clinical trials.

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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue