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- FDA Proposes Rule to Modernize Drug Manufacturing RegistrationThe U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a…fda press · 19d ago↗ source
- FDA Approves First Gene Therapy for Young Children with Sickle Cell DiseaseThe U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…fda press · 28d ago↗ source
- FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer PatientsThe U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult pat…