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 ...

Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the ...

Disc Medicine’s effort to introduce a new therapy for a rare blood disorder with few treatment options has been derailed with the FDA turning down the application and asking for more data from another ...

Sarah Jividen, RN, BSN, is a trained neuro/trauma, and emergency room nurse turned healthcare writer. As a journalism major, she combined her love for writing with her passion for high-level patient ...

The FDA in October 2025 granted bitopertin its Commissioner’s National Priority Voucher but after a shortened review time has decided the data did not support regulatory approval for treating ...

FORT MYERS, Fla. – For Alex Cora’s eighth full-squad meeting as Red Sox manager, he decided to “switch the whole script.” The Red Sox spent two weeks gathering video messages from players’ and coaches ...

The Red Sox go into the 2026 season with expectations to not just make the postseason, but have a longer run than 2025 that ended after the American League Wild Card. The World Series is always the ...

The Boston Red Sox are still making some roster moves as Spring Training gets underway, but for the most part, the team’s offseason work is over. Manager Alex Cora has begun the process of identifying ...

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 ...

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 ...

Some call it a problem and some call it a luxury, but whatever you call it, the Boston Red Sox outfield is a logjam. With five mouths to feed who are all capable big league players with different ...

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 ...