Engineered biologics win FDA nod, opening doors across the blood–brain barrier

TL;DR Summary
The first FDA-approved engineered biologic that can cross the blood–brain barrier marks a milestone in CNS drug delivery, as researchers accelerate brain-shuttle approaches to ferry large-molecule therapies into the brain for potential treatments of neurological diseases.
- Brain-shuttle biologics chart new paths across the blood–brain barrier Nature
- The blood-brain barrier lets glucose and ketones cross freely, but blocks 98% of small-molecule drugs — and the tight junctions doing the filtering are only about 4 nanometers wide ScienceBlog.com
- Blood-Brain Barrier Crossed: Denali’s FDA Approval Unlocks Alzheimer’s Pipeline Tech Times
- Denali CEO to open AAIC 2026 with brain-delivery plan for Alzheimer’s Stock Titan
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