regulatory approval
AbbVie's Elahere Approved in Europe for FRα-Positive Ovarian Cancer
Elahere's companion diagnostic, Roche's Ventana FOLR1 (FOLR1-2.1) RxDx assay, also garnered CE marking.
FDA Approves Autolus' CAR T-Cell Therapy Aucatzyl for B-Cell Acute Lymphoblastic Leukemia
The agency reviewed data from the FELIX trial, in which 63 percent of patients achieved a complete remission on the cell therapy at any time point.
NeoGenomics Wins New York State Approval for Solid Tumor, Lung Cancer NGS Tests
Although the approval is conditional, the company can now offer the tests for physicians and patients in the state.
FDA Approves Astellas' Vyloy, Chemo in First-Line CLDN18.2-Positive Gastric Cancer With Roche CDx
Vyloy is the first CLDN18.2-targeted treatment to reach the US market alongside Roche's Ventana CLDN18 RxDx Assay for identifying eligible patients.
Astellas' Vyloy Approved in Europe as First-Line Treatment for CLDN18.2-Positive Gastric Cancer
The European Commission approval was based on two Phase III trials showing Vyloy plus chemo improved survival outcomes versus chemo alone.
Mar 1, 2024