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.
The European Medicines Agency has validated its Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer.
FDA has finalized a rule to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.
FDA issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors-1, -2, and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer.
FDA has approved ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
