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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 ...
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 ...
STAT2d
Vertex stem cell therapy spurs insulin independence
Good morning! Today, we get deeper into the ousting of Nicole Verdun at the FDA, see promise from Vertex’s cell therapy for ...
Fierce Biotech6d
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 ...
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 ...
Pharmaceutical Technology 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 ...
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, ...
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 ...
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 ...
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 will not convene its panel of outside experts before deciding on the company's cell therapy for a heart condition associated ...
Fierce Pharma3d
FDA's acting CDER head Jacqueline Corrigan-Curay heads for the exit amid period of heavy turnover: reports
In the wake of Marks' exit, FDA Commissioner Marty Makary, M.D., named Vinay Prasad, M.D., to head up the CBER. In addition to that title, Prasad recently added the title of "chief medical and science ...