Disc Medicine to pursue traditional U.S. approval after FDA rejects new fast-track route

 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.

https://finance.yahoo.com/news/disc-medicine-pursue-traditional-u-134352142.html