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April 21, 2025

US FDA clears Calidi’s CLD-201 for clinical development in solid tumours

The US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for CLD-201, an allogeneic stem cell-based immunotherapy developed by Calidi Biotherapeutics, set to advance into clinical development for solid tumours.

US FDA clears Calidi’s CLD-201 for clinical development in solid tumours