After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer ...

Astellas Pharma's drug Vyloy was approved for treatment of advanced gastric and gastroesophageal junction cancer by the Food and Drug Administration.

Astellas Pharma Inc. (ALPMY, ALPMY) said that the U.S. Food and Drug Administration has approved VYLOY (zolbetuximab-clzb) in ...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) in combination ...

VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive TOKYO, Oct. 18 ...

The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's ...

FDA's approval of Astellas' therapy for gastric cancer, and CVS Health's leadership shuffle as Karen Lynch steps down amid ...

FDA also approved the Ventana CLDN18 (43-14A) RxDx Assay, from Ventana Medical Systems, Inc. and Roche Diagnostics, to ...

Roche has gained the Conformité Européenne (CE) mark of approval for its VENTANA CLDN18 (43-14A) RxDx assay to identify ...

Roche Holdings said it received Food and Drug Administration approval for its companion diagnostic of gastric and gastroesophageal junction cancer.

adenocarcinoma eligible for targeted therapy with Astellas’ VYLOY (zolbetuximab). The approval introduces the first immunohistochemistry (IHC) companion diagnostic test to determine Claudin 18 ...

Vyloy is the first CLDN18.2-targeted treatment to reach the US market alongside Roche's Ventana CLDN18 RxDx Assay for identifying eligible patients.