Disc Medicine to pursue traditional U.S. approval after FDA rejects new fast-track route
- - Disc Medicine to pursue traditional U.S. approval after FDA rejects new fast-track route
ReutersFebruary 17, 2026 at 6:43 AM
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FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly//File Photo
Feb 17 (Reuters) - Disc Medicine 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)
Source: “AOL Breaking”
