Posted by Michael Wonder on 07 Jan 2021
RedHill Biopharma's RHB-204 granted FDA fast track designation for non-tuberculous mycobacteria disease
6 January 2021 - FDA Fast Track designation, together with previously granted QIDP designation, provides RHB-204 with eligibility for rolling NDA review, Priority Review and Accelerated Approval.
RedHill Biopharma today announced that RHB-204 has been granted Fast Track designation by the U.S. FDA for its development as a potential first-line, stand-alone, oral treatment of pulmonary non-tuberculous mycobacteria disease caused by Mycobacterium avium Complex – a rare disease for which there is no FDA approved first-line therapy.
