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 ...

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

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 ...

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 ...

Image created by Zhi Yang, PhD, Professor at Nuclear Medicine Department, Peking University Cancer Hospital, PR China.

Roche has announced the CE certification of its VENTANA CLDN18 (43-14A) RxDx Assay, marking a significant advancement in ...

The updated findings from the Phase I monotherapy dose-escalation and expansion study in patients with CLDN18.2 positive gastric, esophageal, and gastroesophageal junction (GEJ) cancers ...

The assay's ability to determine CLDN18.2 status is pivotal for clinicians to identify patients who may benefit from CLDN18.2 targeted therapy, such as VYLOY. VYLOY is the first approved treatment ...