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

The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.

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

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

Shares of Capricor Therapeutics (CAPR) tumbled 16% on Friday morning following reports that Nicole Verdun, director of the office that reviews cell and gene therapies at the Food and Drug ...

Nicole Verdun, who headed the office that reviews cell and gene therapies at the Food and Drug Administration, was placed on administrative leave and escorted out of the agency along with her ...

Nicole Verdun, director of the office that reviews cell and gene therapies at the Food and Drug Administration, and her deputy Rachael Anatol have been placed on administrative leave and ...

In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, the agency is investigating two Duchenne muscular dystrophy patient deaths ...

“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.

Dr. Nicole Verdun, who was hired to head the new FDA initiative last year, said Lenmeldy’s approval is a sign that things are moving in the right direction.

Exa-cel has been studied for treatment of sickle cell disease with severe vaso-occlusive crises and has shown efficacy and safety," Dr. Nicole Verdun, head of the FDA's Office of Therapeutics ...