BETA
Your AI-Trained Oncology Knowledge Connection!
EP. 1: FDA Grants Breakthrough Designation for Novel Bladder Cancer Diagnostic
The FDA designates the TOBY Test as a breakthrough device, revolutionizing bladder cancer detection with a non-invasive, AI-driven urine test.
EP. 2: Novel Acoustic Coupling Fluid Earns FDA Breakthrough Status for Enhanced Neurosurgical Imaging
The SonoClear System revolutionizes neurosurgery with FDA breakthrough designation, enhancing ultrasound imaging for safer tumor resections in glioma surgeries.
EP. 3: FDA Greenlights Linvoseltamab in Relapsed/Refractory Multiple Myeloma
Linvoseltamab represents a promising new approach to treating multiple myeloma through immune-based therapy.
EP. 4: FDA Accelerates Approval of Sunvozertinib for EGFR Exon 20+ NSCLC
FDA accelerates approval of sunvozertinib for advanced NSCLC with EGFR mutations, offering new hope for patients after chemotherapy.
EP. 5: FDA Clears Oncomine Dx Express Test for Sunvozertinib in EGFR Exon 20+ NSCLC
The FDA approves a rapid test for identifying patients with NSCLC eligible for sunvozertinib, enhancing timely, precision oncology care.
EP. 6: FDA Approves SIR-Spheres Y-90 for First-Line Use in Unresectable HCC
The FDA approves SIR-Spheres Y-90 microspheres for treating unresectable hepatocellular carcinoma, showcasing impressive efficacy and safety in clinical trials.
EP. 7: FDA Grants Orphan Drug Designation to Liposomal Gemcitabine in Biliary Tract Cancer
FDA designates FF-10832 as an orphan drug for biliary tract cancer, promising enhanced treatment options for this aggressive malignancy.
EP. 8: FDA Orphan Drug Status Granted for CAR T-Cell Therapy in Malignant Gliomas
FDA designates MB-101 CAR T-cell therapy for glioblastoma, highlighting its potential in treating aggressive brain tumors with innovative combination strategies.
EP. 9: FDA Draft Guidance Illuminates MDS Drug Development Pathways
EP. 10: FDA Grants Orphan Drug Status to STEAP1-Targeting ADC for Gastric Cancer
Adcentrx Therapeutics advances gastric cancer treatment with FDA orphan drug designation for ADRX-0405, a promising antibody-drug conjugate in clinical trials.
EP. 11: FDA-Approved Denosumab Biosimilars Expand Oncology Options in US
Celltrion USA launches 2 denosumab biosimilars, Stoboclo and Osenvelt, enhancing treatment options for osteoporosis and cancer-related skeletal issues.
EP. 12: FDA Reviews All-Oral Decitabine/Cedazuridine/Venetoclax Combo in AML
The FDA reviews an all-oral treatment for newly diagnosed AML, combining decitabine, cedazuridine, and venetoclax, showing promising trial results.
