Cartography Biosciences Inc. has entered a strategic collaboration agreement with Gilead Sciences Inc., to discover and develop therapies for patients with triple-negative breast cancer and the most common form of non-small cell lung cancer, adenocarcinoma.
FDA’s Medical Devices Advisory Committee has strongly recommended FDA approval of Guardant Health’s Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease.
FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.
FDA has reassigned the previously announced Prescription Drug User Fee Act goal date of Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20).
FDA Oncology Center of Excellence has formed the OCE Equity Program.
Parexel, one of the world’s largest clinical research organizations providing the full range of phase I to IV clinical development services, has released a new report in their expert series, New Medicines, Novel Insights.
FDA and the European Medicines Agency granted an Orphan Drug Designation to Carthera for the use of carboplatin when used with SonoCloud technology in the treatment with malignant glioma.
Leal Health announced a first-of-its-kind GenAI single point of access technology designed to allow healthcare providers, caregivers, and cancer patients to understand diagnostics and identify personalized treatment options to support the treatment decision process.
The Centers for Medicare & Medicaid Services recently issued a decision to expand Medicare coverage for allogeneic hematopoietic stem cell transplants for eligible Medicare patients with myelodysplastic syndromes, based on decades-long research led by investigators at the Medical College of Wisconsin Cancer Center, in collaboration with investigators in the Blood and Marrow Transplant Clinical Trials Network and advocacy experts at the American Society of Hematology, American Society for Transplantation and Cellular Therapy, and the National Marrow Donor Program.
FDA has accepted the Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20)—herein referred to as “subcutaneous nivolumab”—across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
