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RedHill and Cosmo Strengthen Manufacturing Agreements
contractpharma
February 20, 2021
Secures manufacturing capacity of Movantik for opioid-induced constipation and RHB-204, currently in a Phase 3 study for pulmonary NTM disease.
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RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease
americanpharmaceuticalreview
January 14, 2021
RedHill Biopharma announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) ...
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RedHill Biopharma Initiates Study of RHB-204 for NTM Disease
americanpharmaceuticalreview
December 08, 2020
RedHill Biopharma has initiated its Phase 3 study to evaluate the safety and efficacy of RHB-204 as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) ...
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RedHill Biopharma Initiates Phase 3 Study of RHB-204 for First-Line Treatment of NTM Disease
prnasia
November 23, 2020
RHB-204 is being evaluated as a first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease - a rare condition with no FDA-approved first-line therapy.
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RedHill Announces Orphan Drug Designation for NTM Infection Treatment
americanpharmaceuticalreview
October 22, 2020
RedHill Biopharma announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to RHB-204 for the treatment of nontuberculous mycobacteria (NTM) disease.