Federal regulatory agency division
Appears in 2 stories
Reviewing cardiac regeneration therapies for clinical approval
Researchers just demonstrated they can regenerate heart muscle using reprogrammed stem cells—and for the first time, proved these patches work in a human patient. In January 2025, a 46-year-old woman with advanced heart failure received 10 patches containing 400 million stem cell-derived heart muscle cells. Three months later, when she received a transplant, examination of her original heart revealed the patches had survived, formed blood vessels, and integrated with her heart tissue.
Updated May 21
Reviewing gene therapy approvals and safety
For three years, Sarepta Therapeutics has been the only company in the world selling a gene therapy for Duchenne muscular dystrophy. Regenxbio's trial result on May 14, 2026, sets up a second contender for U.S. Food and Drug Administration (FDA) approval.
Updated May 14
No stories match your search
Try a different keyword
How would you like to describe your experience with the app today?
