Shares of Foghorn Therapeutics were falling rapidly in premarket trading Tuesday after the company announced the FDA placed a full clinical hold on a Phase I dose escalation study. The trial had already been subject to a partial hold following a patient death.
Tag Archive for: myelodysplastic syndrome (MDS)
Advisers to the U.S. Food and Drug Administration on Thursday voted to recommend approval of bluebird bio’s treatment for a rare neurological disorder, bringing it closer to becoming the third gene therapy to be available in the United States.
Bluebird bio’s blood disorder treatment demonstrates “clinically meaningful” benefit in patients, staff reviewers at the U.S. Food and Drug Administration said in briefing documents published on Tuesday.
