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

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

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...

Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...

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

Stat reported Nicole Verdun, M.D., director of the FDA’s cell and gene therapy office, and her deputy Rachael Anatol, Ph.D., were relieved of their duties without being given an explanation.

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

Nicole Verdun, director of the FDA’s office that reviews cell and gene therapies, and her deputy Rachael Anatol were reportedly escorted out of the agency, according to information obtained and ...

Investing.com -- Capricor Therapeutics Inc (NASDAQ: CAPR) stock tumbled 20.4% following news that two top FDA officials overseeing cell and gene therapies have been placed on administrative leave.

Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain ...

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