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Zanidatamab-hrii received FDA accelerated approval for HER2-positive biliary tract cancer, showing a 52% objective response rate in the HERIZON-BTC-01 trial. Biliary tract cancers represent 3% of ...

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) ...

The Company plans to submit an sBLA for the GEA indication in the first half of 2026. Topline data were announced from a phase 3 study evaluating zanidatamab-hrii for the first-line treatment of human ...

Please provide your email address to receive an email when new articles are posted on . Researchers reported a 41% confirmed ORR among patients with HER2-positive disease. No patients with ...

Confirmed objective response rate (cORR) of 75% overall and 93% for the proposed Phase 3 regimen (zanidatamab + CAPOX/FP) Median duration of response (mDOR) of 16.4 months and median progression free ...

Elena Elimova, MD, shares efficacy data for zanidatamab in patients with HER2-positive gastroesophageal adenocarcinoma from HERIZON-GEA-01. What the main findings of the study were was that number 1, ...

Please provide your email address to receive an email when new articles are posted on . CHICAGO — Zanidatamab exhibited durable antitumor activity among patients with previously treated advanced ...

Data from Phase 1b/2 trial presented at ESMO Breast Cancer 2026 further validate a biomarker-driven development strategy for evorpacept - - ...

A Prescription Drug User Fee Act target date has been set for August 25, 2026. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application ...

Preliminary study results examining the bispecific antibody, CDK4/6 inhibitor and hormone therapy combination in patients with advanced breast cancer were presented at SABCS. Treatment with bispecific ...