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

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

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

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 ...

Vyloy is the first CLDN 18.2-targeted treatment to reach the US market alongside Roche's Ventana CLDN18 RxDx Assay for identifying eligible patients.

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

The US FDA has approved AbbVie's VYALEV to treat motor fluctuations in adults with advanced Parkinson's disease (PD).

The FDA has already made more than a dozen cancer drug approval decisions this year and more expected in the next several ...

For disease-specific survival in malignant adnexal tumors of the skin, Mohs micrographic surgery is superior to wide local excision and no treatment.