Mainz Biomed, a molecular genetics diagnostic company specializing in the early detection of cancer, announced a collaborative agreement with Thermo Fisher Scientific Inc. through its subsidiary Life Technologies Corporation.
FDA has approved MI Cancer Seek for use as a companion diagnostic to identify patients with cancer who may benefit from treatment with targeted therapies.
Scemblix (asciminib) was granted accelerated approval by FDAÂ for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
Pangea Biomed, a startup developing the Enlight cancer response prediction platform, announced the beginning of a pilot collaboration with the Knight Cancer Institute at Oregon Health and Science University.
FDA has approved Vyloy (zolbetuximab-clzb), a claudin 18.2-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.
FDA has accepted the New Drug Application for TLX101-CDx (Pixclara), an agent for the imaging of glioma.Â
The European Commission has approved two new indications for Keytruda (pembrolizumab), an anti-PD-1 therapy, in gynecologic cancers.
The European Medicines Agency Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of trifunctional anti-CD3 x anti-EpCAM antibody Korjuny (catumaxomab) for the intraperitoneal treatment of malignant ascites in adults with EpCAM-positive carcinomas who are not eligible for further systemic anticancer therapy.
The European Medicine Agency Committee for Medicinal Products for Human Use issued positive opinions recommending an extended authorization for Tevimbra (tislelizumab) in gastric or gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
EMA has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia and Xgeva (denosumab).
