The FDA is reviewing the Biologics License Application (BLA) submission from Capricor Therapeutics regarding its therapeutics for Duchenne Muscular Dystrophy (DMD).
3 reports, 1 independent
Updated Aug 26
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What happened
The FDA is reviewing the Biologics License Application (BLA) submission from Capricor Therapeutics regarding its therapeutics for Duchenne Muscular Dystrophy (DMD).
Who's involved
What this event is mainly aboutKeep exploring
Part of
Capricor Therapeutics is seeking regulatory approval from the FDA for therapeutics targeting Duchenne Muscular Dystrophy.Also in this story
- The FDA announced its decision regarding the Advisory Committee for Capricor Therapeutics' drug, deramiocel, on June 26, 2025.
- Capricor Therapeutics is developing therapeutics for Duchenne muscular dystrophy and had a Type A meeting scheduled with the FDA.
The entities involved
Related events
- A study protocol involving a company based in Mont-Saint-Guibert was approved by the U.S. FDA.
- Data was presented in Athens supporting a future U.S. NDA submission to the FDA.
- A clinical study led by Dr. Swee Lay Thein is underway at the National Institutes of Health and is subject to oversight by the Food and Drug Administration.
- The FDA requested additional clinical data from Unicycive Therapeutics.
- A product was launched in the U.S. market following FDA involvement.
Coverage
Newest first; wire copies grouped- prnewswire.com
- prnewswire.com
- Unknown outlet