Biotech & Medicine
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FDA Grants Fast-Track Designation to First Bioengineered Liver for Acute Liver Failure After Phase 1 Trial Shows Promise
United Therapeutics' miroliverELAP, an external bioengineered liver built on a decellularized pig scaffold seeded with human cells, receives FDA RMAT designation after all five Phase 1 patients survived treatment.
Hair-Thin Nerve Implants Decode Phantom Leg Movements in Above-Knee Amputees, Opening Path to Neurally Controlled Prosthetics
Ultrathin electrodes in the sciatic nerve and a spiking neural network decoder classify phantom leg movements in above-knee amputees, enabling bidirectional motor control and sensory feedback from one device.
Life Biosciences Raises $80 Million to Fund First Human Trial of Epigenetic Cell Rejuvenation
The Boston biotech closes a Series D round to advance ER-100, the first FDA-cleared therapy that uses partial epigenetic reprogramming to reverse cellular aging in humans.
Continuous Glucose Monitors Split Into Two Markets as Year-Long Implants and OTC Wellness Sensors Reshape Diabetes and Consumer Health
Real-world data from the first year-long implantable CGM arrives as over-the-counter glucose biosensors pivot toward AI-driven wellness coaching, splitting the market between clinical precision and consumer accessibility.
Bipartisan Senate Push Builds Toward Psychedelic Therapy for Veterans as Clinical Evidence Mounts
Two bipartisan Senate bills would create a VA Office of Novel Therapeutics and fund psychedelic research centers, while states enact their own laws and Phase 3 trials advance.
Brain Organoid Science Hits an Inflection Point as Therapies Reach Patients, NIH Builds a National Center, and Nature Calls for Regulation
A decade after the first lab-grown brain models, organoid research is crossing from laboratory curiosity to clinical reality, prompting calls for governance frameworks to match the pace of science.
FDA Accepts Ultragenyx's Gene Therapy Application for Sanfilippo Syndrome, Setting September Decision Date for First-Ever Treatment
The FDA has accepted Ultragenyx's resubmitted BLA for UX111, a one-time gene therapy for the fatal childhood disease Sanfilippo syndrome Type A, with a decision expected by September 19, 2026.
Semaglutide Fails to Slow Alzheimer's in Largest GLP-1 Brain Trial, but Biomarker Shifts Keep the Metabolic Hypothesis Alive
Full results from Novo Nordisk's EVOKE and EVOKE+ trials, published in The Lancet, show oral semaglutide had no effect on cognitive decline over two years despite reducing key cerebrospinal fluid markers of neuroinflammation and tau pathology by roughly 10 percent.
Engineered E. Coli Converts Plastic Bottle Waste into Parkinson's Drug in Bioengineering First
University of Edinburgh researchers engineered bacteria to transform PET plastic into levodopa, a frontline Parkinson's medication, achieving 84 percent conversion from industrial waste in a proof-of-concept published in Nature Sustainability.
Epia Neuro Launches with a Minimally Invasive Brain-Computer Interface Designed to Restore Hand Function After Stroke
Epia Neuro emerged from stealth on April 2 with a read/write BCI platform that decodes neural intent and drives a grip-assist prosthetic, targeting first-in-human trials at Lenox Hill Hospital later this year.
First Phase III Trial to Combine a Microbiome Pill with Cancer Immunotherapy Enrolls Over 700 Kidney Cancer Patients
The SWOG S2419 BioFront study is the first large-scale randomized trial testing whether a daily oral bacterial supplement can boost immunotherapy outcomes in advanced kidney cancer.
Johns Hopkins Digital Twin Hearts Achieve 100% Arrhythmia-Free Rate in First FDA-Approved Clinical Trial
The TWIN-VT trial used personalized computational heart models to guide ventricular tachycardia ablation, with all 10 patients remaining arrhythmia-free after more than a year.