Swiss drug major Roche Group (RHHBY) announced Monday that it has received CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, ...

AbbVie (NYSE: ABBV) today announced the European Commission (EC) granted marketing authorization for ELAHERE® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha ...

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

Roche (RHHBY) announced that the VENTANA CLDN18 RxDx Assay is the first U.S. Food and Drug Administration approved immunohistochemistry companion diagnostic for determining CLDN18 protein ...

Roche announced that the VENTANA CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in ...

This is the first US approval for VYLOY, a therapy targeting claudin (CLDN)-18.2-positive tumours identified through an ...

The diagnostic, called the Ventana CLDN18 (43-14A) RxDx Assay, can help determine the status of Claudin 18 protein expression in tumors of cancer patients, helping inform clinicians about the ...

The Ventana CLDN18 (43-14A) RxDx Assay identifies patients eligible for Vyloy treatment. SPOTLIGHT and GLOW trials showed improved progression-free and overall survival with Vyloy. Common side effects ...

In clinical trials, CLDN18.2 positivity was determined by immunohistochemistry on gastric or GEJ tumor tissue specimens with the Ventana CLDN18 (43-14A) RxDx Assay. The Food and Drug ...

1 The VENTANA CLDN18 (43-14A) RxDx Assay from Roche is an FDA-approved IHC test used to help determine CLDN18.2 status. Testing is available in the U.S. at multiple reference laboratories ...

Roche Holdings said it received Food and Drug Administration approval for its companion diagnostic of gastric and gastroesophageal junction cancer. The diagnostic, called the Ventana CLDN18 (43 ...