Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental Biologics License Application for Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2 ...

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the supplemental Biologics License Application (sBLA) ...
Pharmabiz

Jazz Pharma announces US FDA acceptance and priority review of sBLAS for Ziihera combinations in first-line HER2+ locally advanced or metastatic GEA

Jazz Pharma announces US FDA acceptance and priority review of sBLAS for Ziihera combinations in first-line HER2+ locally advanced or metastatic GEA: Dublin Tuesday, April 28, 202 ...
Benzinga.com

Jazz Pharmaceuticals Stock Rallies On Positive Phase 3 Trial Results for Ziihera In Advanced Gastroesophageal Cancer

Jazz Pharmaceuticals Plc (NASDAQ: JAZZ) shares are popping on Monday following the company’s positive results of its Phase 3 HERIZON-GEA-01 trial, which assessed Ziihera in combination with ...
Seeking Alpha

Jazz Pharmaceuticals to Present Pivotal Phase 3 Results of Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal ...

DUBLIN, Dec. 2, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced two abstracts featuring key data for Ziihera ® (zanidatamab-hrii) have been accepted for presentation at ...
Morningstar

Ziihera® (zanidatamab-hrii) Combinations Achieve Unprecedented Results in First-Line HER2+ Locally Advanced or Metastatic GEA Including More Than Two Years Median Overall ...

DUBLIN, Jan. 6, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive efficacy and safety results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera® (zanidatamab ...
Morningstar

Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental Biologics License Application for Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2 ...

DUBLIN, April 27, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the ...

Jazz Pharmaceuticals plc: Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental Biologics License Application for Ziihera (zanidatamab-hrii ...

Prescription Drug User Fee Act (PDUFA) date set for August 25, 2026 For U.S. media and investors only DUBLIN, April 27, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc ...