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STAT6d
Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official
The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...
BioPharma Dive6d
Gene therapy faces fresh uncertainty as two more top FDA officials depart
The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about ...
STAT8d
Top gene therapy regulator forced out at FDA
Nicole Verdun, director of the office that reviews cell and gene therapies at the Food and Drug Administration, and her ...
Fierce Biotech7d
Industry deeply disappointed as FDA reportedly puts cell and gene therapy chief on leave
The Alliance for Regenerative Medicine has voiced deep disappointment about reports that the FDA has put the director of its ...
Gene Therapy Stocks Fall as FDA Pushes Out Another Top Regulator
The HHS said center directors deserve to be supported by managers aligned with aggressive goals “to expeditiously advance ...
Fierce Pharma1d
FDA investigates patient deaths after treatment with Sarepta's Duchenne gene therapy Elevidys
In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...
Capricor says US FDA may not convene expert panel for co's cell therapy
Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration may not seek its outside experts' advice when ...
BioSpace1d
FDA Churn Continues, RFK Faces Congress, Obesity Insights at ADA, BIO2025 Recap
Robert F. Kennedy Jr. testified in front of largely combative congresspeople on vaccine policy, his MAHA report and more; the ...
GEN - Genetic Engineering and Biotechnology News4d
StockWatch: CGT Stocks Fall on FDA Therapeutic Products Upheaval
Nicole Verdun, MD, super office director of the FDA’s Office of Therapeutic Products (OTP) and her deputy Rachael Anatol, PhD ...
BioSpace3d
Acting CDER Head Becomes Latest in String of FDA Leaders to Leave Agency
Curay, who stepped into the role as the agency’s top drug regulator in January, is departing in July, according to an email ...
RealClearMarkets3dOpinion
Medical Breakthroughs Will Be Few Without a Fast-Moving FDA
When Americans imagine the future, it always has a lot to do with flying cars, robot housekeepers, and just about anything ...
GlobalData on MSN6d
FDA cell and gene therapy director exit increases ‘volatility’ for sector
Nicole Verdun, a highly respected individual in the cell and gene therapy space, was placed on administrative leave this week ...