Select Page
7 Hills Pharma: FDA Fast Track Designation for 7HP349

7 Hills Pharma: FDA Fast Track Designation for 7HP349

Mar 9, 2022 | FDA, News, Regulatory

7 Hills Pharma has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s lead clinical-stage immunostimulant 7HP349, combined with a CTLA-4 inhibitor, to treat unresectable or metastatic malignant melanoma if...
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...
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...