Astellas Pharma today announced that the US Food and Drug Administration (FDA) 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 ...

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 ...

Vyloy (zolbetuximab) has been given the go-ahead for use in combination with chemotherapy for the first-line treatment of adults with locally advanced or metastatic HER2-negative, claudin 18.2 ...

B. Braun Medical Inc. (B. Braun), a leader in smart infusion therapy and pain management, provided an update today on the company's efforts to secure supplies of critical IV fluids in response to ...

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