US FDA to convene expert panel for Capricor Therapeutics' DMD cell therapy

US FDA to convene expert panel for Capricor Therapeutics' DMD cell therapy

By Siddhi Mahatole

FDA will ask outside experts to review Capricor's therapy for Duchenne muscular dystrophy

Today's biotech news spans Capricor's therapy for Duchenne muscular dystrophy, overseas grants potentially "closed down" by NIH, and more.

FDA adcomm will review Capricor's cell therapy for Duchenne muscular dystrophy

Capricor Therapeutics' cell therapy for Duchenne muscular dystrophy will face an FDA advisory committee ahead of an approval decision that's expected Aug. 31, the company disclosed on Monday. The San Diego-based company, which saw its ...

US FDA to convene expert panel for Capricor Therapeutics' DMD cell therapy - Finnoexpert

US FDA to convene expert panel for Capricor Therapeutics' DMD cell therapy Source link The post US FDA to convene expert panel for Capricor Therapeutics' DMD cell therapy appeared first on Finnoexpert.

FDA to  hold an advisory committee meeting for Capricor’s deramiocel as part of marketing approval decision

CureDuchenne was an early funder of Capricor Therapeutics, which has announced completion of a mid-cycle review meeting with the U.S. FDA for their investigational cell therapy, deramiocel, for Duchenne cardiomyopathy.  The company is on track for the PDUFA target action date of August 31, 2025, and the FDA has confirmed its intent to hold an advisory committee meeting before that date.  We will continue to share information about that meeting a…