GalNAc exploits millions of rapidly recycling receptors on hepatocytes to deliver siRNA with remarkable efficiency, enabling durable gene silencing after subcutaneous dosing while highlighting the unresolved challenge of extrahepatic RNA delivery.
FDA is actively encouraging organoids, organs-on-chips and computational models as alternatives to some animal studies, but reproducibility, validation and whole-body biology still prevent a simple one-for-one replacement.
Foundayo became the first approved nonpeptide small-molecule GLP-1 obesity drug in 2026, replacing injectable peptide chemistry with a tablet that can be taken without food or water restrictions.
Most FDA-cleared surgical robots still operate under direct human control, while research systems are beginning to automate individual tasks. Moving from task automation to independent surgery requires solving perception, tissue variability, failure recovery and liability.
Therapeutic RNA editing recruits naturally occurring enzymes to rewrite individual RNA letters without permanently changing genomic DNA, trading lifetime correction for reversibility and potentially simpler risk management.
FDA is exploring competency assessment, risk-based monitoring and new lifecycle controls for generative AI medical devices whose outputs can vary by prompt, context and software evolution.
Bispecific T-cell engagers developed for blood cancers are being repurposed to eliminate pathogenic B cells and plasma cells in severe autoimmune disease, potentially offering CAR-T-like depth without individualized cell manufacturing.
Pathology foundation models learn reusable representations from millions of tissue images and can be adapted for cancer detection, biomarkers and prognosis, potentially replacing one-algorithm-per-task development.
Blood tests measuring phosphorylated tau and amyloid-related biomarkers can identify Alzheimer’s-associated brain pathology with high accuracy, but they are not interchangeable with population screening or a complete dementia diagnosis.
Ex-vivo CRISPR edits cells outside the body before reinfusion. In-vivo editing sends the editing machinery directly into a patient, potentially making treatment simpler but far harder to control.