Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Meta-Analysis Questions FDA Warning on Secondary Cancer Risks With CAR T-Cell Therapies
Researchers analyzed two dozen studies and found similar rates of second primary cancers in patients receiving CAR T-cell and standard therapies.
Diamyd Medical Eyeing Accelerated Approval for Immunotherapy in Genomically Defined Diabetes Subset
The firm hopes to submit interim data to the FDA from a study involving stage 3, type 1 diabetes patients with the HLA DR3-DQ2 genotype.
In Brief This Week: Obsidian, Skyline, Mainz Biomed, Novartis, Synthekine, Vivet, Abdera
News items for the week of Sept. 2, 2024.
FDA Clears Medigene's IND for TCR-T Therapy in Certain Advanced Solid Tumors
The firm plans to launch a Phase I trial for the autologous TCR-T cell therapy by year-end if additional funding comes through.
ProKidney Discontinues Late-Stage Trial to Focus on FDA Approval for Cell Therapy
A review suggested to the company that it could seek expedited approval for rilparencel in chronic kidney disease using only PROACT 1 trial results.