JAZZ

ZIIHERA (zanidatamab)

Name: Jazz Pharmaceuticals plc FDA PDUFA Decision
Start: 2026-08-25

FDA PDUFA Target Action Date · Jazz Pharmaceuticals plc

Tuesday, August 25, 2026

Approved

approved

Note: Approved 2026-08-25 as ZIIHERA (SUPPL BLA761416). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.

Drug Information

Drug Name: ZIIHERA (zanidatamab) (CT.gov)
Application Type: sBLA
Indication: first-line HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA)
Approved As: ZIIHERA (zanidatamab)

Filing Details

Company: Jazz Pharmaceuticals plc →
Stock Ticker: JAZZ
SEC CIK: 0001232524
Source: SEC EDGAR (LLM-extracted via partner-company filing — Zymeworks Q1 2026 earnings) →

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 Jazz Pharmaceuticals plc

View Jazz Pharmaceuticals plc's full pipeline, approved drugs, and clinical trials.

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Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue