The Food and Drug Administration granted accelerated approval to zanidatamab-hrii, or Ziihera from Jazz Pharmaceuticals (JAZZ), Inc., a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. The FDA also approved VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody, from Ventana Medical Systems, Roche Diagnostics (RHHBY), as a companion diagnostic device to aid in identifying patients with BTC who may be eligible for treatment with Ziihera.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 55% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on JAZZ:
- Jazz Pharmaceuticals price target lowered to $163 from $166 at Piper Sandler
- Zymeworks, Jazz Pharmaceuticals announce FDA approval of Ziihera
- Jazz Pharmaceuticals announces FDA approval of Ziihera in BTC
- Jazz Pharmaceuticals price target raised to $162 from $154 at Baird
- Biotech Alert: Searches spiking for these stocks today