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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 ...
STAT3d
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 ...
BioPharma Dive2d
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 how gene therapies will be regulated under new FDA leadership.
GlobalData on MSN2d
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 ...
Fierce Biotech2d
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 ...
STAT2d
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 ...
Capricor Therapeutics stock plunges after key FDA officials placed on leave
This leadership vacuum follows another significant departure at the FDA. Peter Marks, former head of the Center for Biologics Evaluation and Research who worked closely with Verdun on establishing new ...
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 ...
Health Care Down on FDA Concerns -- Health Care Roundup
The departure of Food and Drug Administration official Dr. Nicole Verdun, who was in charge of regulating gene therapies and cell therapies, is setting off a new round of worries for biotech investors ...
Benzinga.com2d
STAT+: Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official
The regulator, Nicole Verdun, had scheduled an advisory committee meeting to review the therapy developed by Capricor Therapeutics. But Vinay Prasad, director of the FDA’s Center for Biologics ...
Morningstar2d
Health Care Down on FDA Concerns — Health Care Roundup
The departure of Food and Drug Administration official Dr. Nicole Verdun, who was in charge of regulating gene therapies and cell therapies, is setting off a new round of worries for biotech ...