The US Food and Drug Administration (FDA) has granted fast track designation to SYNCAR-001 + STK-009. The treatment is indicated for patients with severe, refractory systemic lupus erythematosus (SLE), without the use of lymphodepletion. The fast-track designation follows investigational new drug (IND) clearance for a Phase I study evaluating SYNCAR-001 + STK-009 for non-renal SLE […]

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