FDA– tag –
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Cytiva’s ELEVECTA Cell Line Receives FDA AMT Designation, Pioneering Next-Gen AAV Manufacturing with 99% Host Cell DNA Reduction
BioPharma BoardRoom USA Overview Cytiva, a Danaher company, has secured FDA Advanced Manufacturing Technology (AMT) designation for its ELEVECTA transient cell line, designed for adeno-associated virus (AAV) manufacturing. This pioneerin... -
FDA Finalizes Guidance on CMC Flexibility for Cell and Gene Therapies, Expediting Access to Advanced Treatments
Regulatory Focus USA Overview The U.S. FDA has issued final guidance outlining flexible Chemistry, Manufacturing, and Controls (CMC) requirements for cell and gene therapy (CGT) products, recognizing their inherent complexities compared ... -
Precision BioSciences Unveils Promising Preclinical Data for In Vivo Gene Editing Therapy in Duchenne Muscular Dystrophy
Morningstar USA Overview Precision BioSciences has presented encouraging preclinical data for PBGENE-DMD, an in vivo gene editing therapy targeting Duchenne Muscular Dystrophy, at the 2026 ASGCT Annual Meeting. Early intervention in youn...
