In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...

Nicole Verdun's ouster followed a disagreement over review of cell therapy for Duchenne muscular dystrophy, long-simmering tensions over management style.

Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration may not seek its outside experts' advice when deciding on the company's cell therapy for a heart condition associated with ...

Nicole Verdun, top gene therapy regulator at the FDA, has been forced out of the agency.

"Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need," said FDA's Dr. Nicole Verdun.

Nicole Verdun, MD, super office director of the FDA’s Office of Therapeutic Products (OTP) and her deputy Rachael Anatol, PhD, have been placed on administrative leave. The moves led to a 31% ...

Nicole Verdun, a highly respected individual in the cell and gene therapy space, was placed on administrative leave this week.

Capricor Therapeutics (CAPR) stock drops as FDA reportedly cancels an advistory meeting scheduled to review its lead drug Deramiocel. Read more here.

The Food and Drug Administration Friday approved a new sickle cell disease treatment using the CRISPR genome editing technology. It's the first approved human gene editing therapy.

“Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need," the FDA's Dr. Nicole Verdun said in a statement announcing the approvals. “"We ...

The Food and Drug Administration approved two genetic treatments for sickle cell disease, including one that uses gene-editing. The approvals offer hope for patients and signal a new medical era.