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
- Arthur Caplan questioned the FDA regarding the status of clinical trials in 2006.
- The FDA is reviewing the BLA submission from Ultragenyx Pharmaceutical, with Eric Crombez serving as chief medical officer.
- FDA warnings are influencing local regulatory action as a local council addresses substance health risks.
- FDA provided guidance for HCW Biologics' IND application.
- A company submitted study data supporting a PMA submission to the FDA.
Coverage
Newest first; wire copies grouped- prnewswire.com
- prnewswire.com
- Unknown outlet