IHC
Merck Nabs Full FDA Approval for Keytruda in MSI-High, dMMR Solid Tumors
The conversion from accelerated to full approval marks the first time the FDA has granted full approval to an immunotherapy in a tumor-agnostic indication.
Astellas Bullish on Zolbetuximab's Prospects in Gastric Cancer After Two Positive Phase III Readouts
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The firm will submit data from the GLOW and SPOTLIGHT studies to regulators and seek approval for zolbetuximab plus chemo in CLDN18.2-positive HER2-negative advanced gastric cancer.
Novartis Nets FDA Approval for Tafinlar-Mekinist in Pediatric Low-Grade Glioma
Regulators approved Novartis' BRAF/MEK inhibitor combo for kids whose tumors harbor BRAF V600Emutations and simultaneously approved a new liquid form of the treatment.
Roche Nabs FDA Approval for Ventana PD-L1 Test as CDx for Libtayo
The immunohistochemistry test is used to detect programmed death-ligand 1 protein in non-small cell lung carcinoma patients.
FDA Approves Gilead's Trodelvy for HR-Positive, HER2-Negative Metastatic Breast Cancer
The approval expands the antibody-drug conjugate's use beyond triple-negative breast and urothelial cancer and includes patients whose tumors express hormone receptors.