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, ...

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 ...

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 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 ...

The FDA continues to approve new drugs and expand indications for others at a rapid pace. Here’s a summary of what happened ...

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 ...

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 ...