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Axcella: FDA Fast Track for AXA1125 to Treat NASH

Axcella: FDA Fast Track for AXA1125 to Treat NASH

Feb 14, 2022 | FDA, News, Regulatory

The US Food and Drug Administration (FDA) has granted a Fast Track Designation to Axcella Therapeutics’ AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. NASH is the most severe form of fatty liver disease and if left untreated, can lead to...
FDA Awards QIDP Designation to Evofem Biosciences

FDA Awards QIDP Designation to Evofem Biosciences

Feb 10, 2022 | FDA, News, Regulatory

The U.S. Food and Drug Administration (FDA) has awarded Evofem Biosciences a Qualified Infectious Disease Product (QIDP) Designation to EVO100 (Phexxi) for the prevention of chlamydia. Chlamydia has been reported to be responsible for up to half of all pelvic...
VCN Biosciences’ VCN-01 Receives FDA Designation

VCN Biosciences’ VCN-01 Receives FDA Designation

Feb 9, 2022 | FDA, News, Regulatory

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

Feb 7, 2022 | FDA, News, Regulatory

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...