Disc Medicine to pursue traditional U.S. approval after FDA rejects new fast-track route
17/02/2026 13:41
Feb 17 (Reuters) - Disc Medicine IRON.O said on Tuesday it will pursue a traditional U.S. approval pathway for its rare disease drug after the Food and Drug Administration declined to approve the treatment under a new fast-track review program. The drug, bitopertin, was previously reviewed under the FDA's national priority voucher program, which fast-tracks the process to one to two months from the typical 10-12 months. (Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber) ((siddhi.mahatole@thomsonreuters.com;))