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

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

The US Food and Drug Administration has approved Vyloy (zolbetuximab-clzb), a claudin 18.2 (CLDN18.2)-directed cytolytic ...

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

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

The Ministry of Health, Labour and Welfare (MHLW) has cleared Vyloy (zolbetuximab) for use in combination with chemotherapy for patients with HER2-negative CLDN18.2-positive advanced or recurrent ...

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

"Roche’s VENTANA CLDN18 assay gains CE mark" was originally created and published by Medical Device Network, a GlobalData ...

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

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 ...

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

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 ...