FDA is a ticker tracked in our intelligence system with 5 linked articles.
STAT+ profiles Heidi Overton and Erica Schwartz amid a Trump-aligned FDA nomination.
FDA approves Ultragenyx gene therapy and Regeneron secures ultra-rare disease approval, underscoring regulatory momentum for gene therapies and mRNA platforms, per The Readout.
Capricor’s Duchenne cell therapy is at risk of FDA rejection, with the company attempting to stave off the decision.
Trump-loyalist Heidi Overton is the president’s pick to head the FDA, with confirmation likely to hinge on political considerations.
Regulatory scrutiny around Huidagene's disclosures after a patient death; mentions Merck/Moderna mRNA cancer vaccine and a potential FDA leadership nominee—signals regulatory and approval risk in biotech.
Trump to nominate Heidi Overton as FDA commissioner, signaling potential regulatory policy shifts.
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