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STAT3d
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 ...
STAT15h
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 ...
GEN - Genetic Engineering and Biotechnology News1d
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 ...
Stocktwits on MSN3d
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 Biotech4d
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 ...
Investor's Business Daily on MSN3d
The FDA Shake-Up Continues, And Could Impact Genetic Medicines
The latest shake-up at the FDA forced out the top two officials in charge of reviewing cell and gene therapies, analysts said ...
Investing.com India3d
Capricor Therapeutics stock plunges after key FDA officials placed on leave
Investing.com -- Capricor Therapeutics Inc (NASDAQ: CAPR) stock tumbled 20.4% following news that two top FDA officials overseeing cell and gene therapies have been placed on administrative leave.
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 ...
The Grio1y
U.S. approves two sickle cell gene therapies, which doctors hope can cure the painful disorder - TheGrio
“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.
Washington Examiner1y
FDA approves world’s first CRISPR gene-editing drug for sickle cell disease - Washington Examiner
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.
MedPage Today1y
Milestone Gene Therapies for Sickle Cell Disease Greenlit by FDA
Lyfgenia's approval was based on the phase I/II HGB-206 study that showed that 6-18 months post-treatment, 30 of 32 patients had severe vaso-occlusive events resolved, with 28 of them having no ...
Benzinga.com3d
STAT+: Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official - Benzinga
The regulator, Nicole Verdun, had scheduled an advisory committee meeting to review the therapy developed by Capricor Therapeutics. But Vinay Prasad, ...