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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 ...
GEN - Genetic Engineering and Biotechnology News3h
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.
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 ...
Stocktwits on MSN2d
Capricor Stock Slumps 16% On Report Of Key FDA Executive’s Removal, But Retail’s Hopeful About New 4-Year Deramiocel Data
Shares of Capricor Therapeutics (CAPR) tumbled 16% on Friday morning following reports that Nicole Verdun, director of the ...
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 ...
Pharmaceutical Technology 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 ...
MarketWatch1d
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 ...
pharmaphorum2d
FDA blocks trials that send US cells to 'hostile' countries
The FDA has launched a review of clinical trials that plan to send American citizens' living cells to 'hostile' countries – ...
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 ...
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 ...