RedHill Biopharma Ltd. (RDHL) said Wednesday that the U.S. Food and Drug Administration or FDA has granted Fast Track designation to RHB-204 for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC). This is a rare disease for which there is no FDA-approved first-line therapy.
The FDA's Fast Track designation is intended to help progress development and speed up the review of novel therapies for serious conditions for which there is an unmet medical need.
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