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VCN Biosciences’ VCN-01 Receives FDA Designation

VCN Biosciences’ VCN-01 Receives FDA Designation

Synthetic Biologics has announced that VCN Biosciences has received an Orphan Drug Designation from the US Food and Drug Administration (FDA) for their therapy, VCN-01, to treat retinoblastoma. Retinoblastoma is a rare cancer of the eye that develops from immature...
NGM Bio’s NGM621 Receives FDA Fast Track Designation

NGM Bio’s NGM621 Receives FDA Fast Track Designation

The US Food and Drug Administration (FDA) has granted a Fast Track designation to NGM Bio’s NGM621 for the treatment of patients with geographic atrophy (GA) secondary to age-related macular degeneration. GA is an advanced form of age-related macular degeneration and...
BioCardia: CardiAMP System to Treat Heart Failure

BioCardia: CardiAMP System to Treat Heart Failure

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the BioCardia’s CardiAMP® Cell Therapy System designed for the treatment of heart failure. Heart Failure (HF) is a complex, progressive clinical syndrome that affects the...