Tag: #GeneEditingRegulation #PrecisionMedicineBreakthrough #RareDiseaseTherapeutics

  • FDA Unveils Regulatory Pathway for Personalized Gene Editing: A Paradigm Shift in Rare Disease Treatment

    FDA Unveils Regulatory Pathway for Personalized Gene Editing: A Paradigm Shift in Rare Disease Treatment

    The landscape of precision medicine underwent a transformative recalibration on October 31, 2025, when the United States Food and Drug Administration disclosed plans to establish an accelerated regulatory framework for personalized gene-editing therapeutics. This unprecedented initiative, championed by Vinay Prasad who oversees gene therapies at the agency, represents a fundamental departure from conventional pharmaceutical approval…