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October 14, 2020 11:00 ET | Source: RedHill Biopharma Ltd.

RedHill Biopharma Announces FDA Orphan Drug Designation for RHB-204 for the Treatment of NTM Infections

RHB-204 Phase 3 study in pulmonary NTM infections is planned to be initiated in the coming weeks--Orphan Drug Designation, along with RHB-204’s FDA QIDP priority designation, will extend U.S....
July 31, 2020 07:00 ET | Source: RedHill Biopharma Ltd.

RedHill Biopharma Announces FDA Clearance for Pivotal Phase 3 Study with RHB-204 for NTM Infections

RHB-204 is a potential first-line oral treatment for pulmonary nontuberculous mycobacteria (NTM) infections, a rare disease with no FDA-approved first-line therapy --The pivotal Phase 3 study aims to...