Signal
71 articles covering "fda"
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.
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.
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.
Three participants in the Acclaim cochlear implant trial have completed their primary 12-month evaluations, bringing the first fully implanted cochlear implant closer to FDA submission.
The FDA has cleared Butterfly Network's Gestational Age Tool, the first blind-sweep ultrasound AI authorized for U.S. marketing, letting any healthcare worker estimate fetal age in under two minutes.
The Eleventh Circuit upholds Florida's cultivated meat ban as Australia launches consumer retail, splitting the global market between expansion and prohibition.
The FDA granted Breakthrough Device Designation to Nia Therapeutics' 60-channel Smart Neurostimulation System, a closed-loop brain implant that uses machine learning to detect impaired memory encoding and deliver targeted stimulation, marking the first such designation for TBI-related memory loss.
Rocket Pharmaceuticals' Kresladi becomes the first gene therapy approved for LAD-I, an ultra-rare immune disorder that leaves children vulnerable to fatal infections.
Novo Nordisk's Awiqli reduces basal insulin injections from 365 to 52 per year, winning FDA approval after a 2024 rejection over manufacturing and safety concerns.
Brepocitinib, a first-in-class TYK2/JAK1 inhibitor, hit all primary and secondary endpoints in the largest-ever dermatomyositis trial, offering the first steroid-sparing treatment for a disease that has lacked targeted therapy for decades.
Johnson & Johnson's Icotyde (icotrokinra), a once-daily oral peptide that blocks the IL-23 receptor, became the first targeted oral therapy to match biologic-level skin clearance in moderate-to-severe plaque psoriasis, marking a potential paradigm shift away from injectable treatments.
The U.S. government is simultaneously encouraging universal wearable adoption through an HHS advertising campaign and loosening FDA oversight of wellness devices, while the health data these sensors generate remains largely unprotected by federal privacy law.