U.S. FDA ACKNOWLEDGES ASTELLAS' RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND SETS NEW ACTION DATE

If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal junction cancers as the first and only CLDN18.2-targeted therapy in the U.S. TOKYO, May 30, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company's resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class i ...