Capricor Therapeutics is seeking regulatory approval from the FDA for therapeutics targeting Duchenne Muscular Dystrophy.
3 reports, 1 independent
Updated Aug 12
Gone quiet
- Reports
- 3
- Developments
- 6
- Repetition
- 33%
New informationRepeats or wire copies
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
What happened
Capricor Therapeutics is seeking regulatory approval from the FDA for therapeutics targeting Duchenne Muscular Dystrophy.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- The FDA is reviewing the Biologics License Application (BLA) submission from Capricor Therapeutics regarding its therapeutics for Duchenne Muscular Dystrophy (DMD).Sub-event
- The FDA informed Capricor Therapeutics that regulatory review is not required for its drug.Sub-event
- The FDA announced its decision regarding the Advisory Committee for Capricor Therapeutics' drug, deramiocel, on June 26, 2025.Sub-event
- Capricor Therapeutics is developing therapeutics for Duchenne muscular dystrophy and had a Type A meeting scheduled with the FDA.Sub-event
Capricor Therapeutics filed for regulatory approval for its Duchenne Muscular Dystrophy therapy.1 source
- FDA indicated Advisory Committee meeting is not required for Capricor Therapeutics' drug application.
Keep exploring
The entities involved
- FDA
-
Capricor Therapeutics (United States)
company in Beverly Hills, United States
Nothing else this week.
Related events
- Arthur Caplan questioned the FDA regarding the status of clinical trials in 2006.
- Research advances have led to the approval of new therapies by the FDA.
- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
- Beren Therapeutics' medicine is under FDA review, coinciding with a CNS meeting held in Montréal, Canada.
- Arise is seeking FDA approval for a drug as of October 7, 2026.
Coverage
Newest first; wire copies grouped- GlobeNewswireCapricor Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update Type A meeting with U.S. FDA scheduled to discuss Deramiocel BLA and path toward potential approval C
- GlobeNewswireCapricor Therapeutics and Parent Project Muscular Dystrophy to Host Webinar to Review Latest Developments in the Deramiocel Program for the Treatment of Duchenne Muscular Dystrophy – Webinar to be he
- Unknown outlet