Astellas Pharma today announced that the US Food and Drug Administration (FDA) has approved VYLOY (zolbetuximab-clzb) in ...

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 ...

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

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

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

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

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

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

RxDx Assay to identify patients with gastric or GEJ cancer gets CE Mark approval: Basel Friday, October 11, 2024, ...

The IHC companion diagnostic test determines CLDN18 protein expression and may help identify patients who are eligible for treatment with Vyloy.