Reuters

Disc Medicine eyes standard US approval for drug after FDA denies fast-track nod

Feb 17 (Reuters) - Disc Medicine (IRON.O), opens new tab 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 ...
Reuters

US FDA declines to approve Disc Medicine's rare disease drug

Feb 13 (Reuters) - Disc Medicine (IRON.O), opens new tab said on Friday the U.S. Food and Drug Administration declined to approve its drug to treat a rare genetic disorder. The drug, bitopertin, was ...
FierceBiotech

FDA rejects Disc's rare disease drug despite commissioner's voucher

The FDA has rejected a rare blood disease candidate from Disc Medicine, a compound that had been granted expedited review through a newly launched priority voucher program. While the agency agreed ...
STAT

FDA rejects rare disease therapy from Disc Medicine, early recipient of commissioner’s ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Adam Feuerstein is a senior ...