TheraRadar
BMY

Bristol-Myers Squibb Company

FDA PDUFA Target Action Date

Monday, August 17, 2026
83 days away

Drug Information

Application Type
NDA
FDA Designations
BreakthroughPriority Review
Indication
Relapsed or refractory multiple myeloma

Filing Details

Stock Ticker
BMY
SEC CIK
0000014272

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 Bristol-Myers Squibb Company

View Bristol-Myers Squibb Company'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