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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...