Federal regulatory agency division
Appears in 2 stories
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 3 hours ago
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. When your heart suffers a heart attack, scar tissue normally replaces dead muscle cells permanently. Adult human hearts renew less than 1% of their cells per year. This damage has been irreversible—until now.
Updated Jan 11
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