fda

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.

The FDA is simultaneously overhauling its GRAS ingredient notification system, phasing out petroleum-based food dyes by year-end, and confronting PFAS contamination in produce, marking the broadest transformation of US food chemical regulation since the 1958 Food Additives Amendment.

Insulet has initiated a voluntary recall of certain Omnipod 5 insulin pump pods after a manufacturing defect caused insulin to leak inside the device rather than reaching patients, leading to 18 serious adverse events including hospitalizations for diabetic ketoacidosis.

China's NMPA approves the world's first commercial brain implant while a BrainGate study demonstrates 110-character-per-minute typing, marking a pivotal week for neural interface technology.

Takeda's oveporexton, an oral drug that restores the brain chemical missing in narcolepsy type 1, has received FDA priority review after two Phase 3 trials showed it brought patients to near-normal wakefulness and cut cataplexy episodes by more than 80 percent.

The FDA has cleared Intellia Therapeutics to resume its MAGNITUDE Phase 3 trial of nexiguran ziclumeran for ATTR cardiomyopathy, five months after a patient death and subsequent clinical hold prompted a safety overhaul.