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

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

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. Skip to Main Content.

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 escorted ...

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, 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% ...

Dr Nicole Verdun, director of the FDA’s Office of Therapeutic Products (OTP), and her deputy Dr Rachael Anatol, were placed on administrative leave on 18 June.

“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.

“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.

Regulators on Friday approved two gene therapies for sickle cell disease that doctors hope can cure the painful, inherited blood disorder that afflicts mostly Black people in the U.S.