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The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...
By Bhanvi Satija (Reuters) -The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop ...
The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...
In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...
“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.
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 ...
The Food and Drug Administration has approved the world's first medicine employing CRISPR gene-editing technology to treat sickle cell disease, giving thousands new hope to treat the painful disease.
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.
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