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

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 ...

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

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

Zolbetuximab — now with the brand name Vyloy — is a monoclonal antibody to treat patients with advanced gastric and ...

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

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

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

The FDA approved zolbetuximab (Vyloy), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, in combination with ...

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