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....

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...