Roche (RHHBY) announced that it has received CE Mark for its Ventana FOLR1 RxDx Assay. This is the first immunohistochemistry, or IHC, ...

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 ...

NEW YORK – The European Commission (EC) on Monday granted marketing authorization to AbbVie's Elahere (mirvetuximab soravtansine) as a new therapy option for previously treated patients with folate ...

Alongside the drug approval, the FDA also okayed the Ventana CLDN18 (43-14A) RxDx Assay (Ventana Medical Systems, Inc. and Roche Diagnostics) to identify claudin 18.2–positive tumors.

RxDx Assay (Roche). Both the SPOTLIGHT study (Vyloy plus the combination of mFOLFOX6 chemotherapy regimen of oxaliplatin, leucovorin, and fluorouracil versus placebo plus mFOLFOX6) and the GLOW ...

This is the first US approval for VYLOY, a therapy targeting claudin (CLDN)-18.2-positive tumours identified through an FDA-approved diagnostic assay, Roche's VENTANA CLDN18 (43-14A) RxDx assay.

The FDA also approved the VENTANA CLDN18 (43-14A) RxDx Assay, a test to detect CLDN18.2-positive tumors and confirm eligibility for the new treatment. The approval was based on results of two ...

Additionally, VENTANA FOLR1 (FOLR1-2.1) RxDx Assay – Roche’s immunohistochemistry (IHC) companion diagnostic for identifying ovarian patients eligible for ELAHERE – has been ...

RxDx Assay is the first U.S. Food and Drug Administration (FDA) approved immunohistochemistry (IHC) companion diagnostic for determining CLDN18 protein expression in tumours of patients with gastric ...