Ingenium Therapeutics has received FDA clearance to proceed directly to Phase 2 trials for Gengleucel in measurable residual disease-positive acute myeloid leukemia, bypassing the typical Phase 1 requirement.
Artiva Biotherapeutics has received FDA Fast Track designation for AlloNK therapy in autoimmune diseases, potentially accelerating development through enhanced agency communication and rolling application options.
NKGen Biotech's innovative NK cell therapy troculeucel has received FDA Fast Track Designation for treating moderate Alzheimer's disease, potentially accelerating its development pathway.
Century Therapeutics' CNTY-101, an iPSC-derived CD19 CAR-iNK cell therapy, will be assessed in a Phase 1/2 trial for B-cell mediated autoimmune diseases.
The combination of Monjuvi, Revlimid, and Rituxan significantly reduces the risk of disease progression or death in relapsed/refractory follicular lymphoma patients.
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