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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.

The trials will assess the therapy’s safety, tolerability, and initial effectiveness in patients with challenging cancers. Credit: National Cancer Institute by Unsplash.