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RHB-204, Oral Treatment for MAC Lung Infections, Put on FDA Fast Track

The U.S. Food and Drug Administration (FDA) has given fast track designation to RedHill Biopharma’s RHB-204 as a potential first-line and stand-alone, oral treatment for lung infections caused by Mycobacterium avium complex (MAC), a type of non-tuberculous mycobacteria (NTM). This designation is given to therapies that show considerable potential in addressing serious conditions for which available treatments fall short. It is meant to speed their clinical development, regulatory review — enabling a rolling review —…