A Nature Medicine study finds GPT-5.2, Gemini 3.1 Pro, and Claude Opus 4.6 outperform FDA-cleared clinical AI tools on...
43% of FDA-authorized AI clinical tools lack published validation data. A Columbia-led research network is building the governance framework...
A UCSF randomized trial of adaptive DBS in Parkinson's gait published in Nature Medicine signals a coming wave of...
Nature Biotechnology's Perturb-DBiT maps CRISPR perturbations in native tissue — and exposes why dissociated-cell screens keep producing trials that...
A Nature Reviews Drug Discovery analysis of EMA post-authorization studies exposes systematic gaps in how conditional approvals convert to...
A rare gene therapy-linked cancer case exposes the gap between FDA's 15-year CAR-T surveillance mandate and real-world monitoring systems...
China's CDE accepted 3,073 IND applications in 2024, up from 70 in 2015. For global trial sponsors, that seismic...
The NordICC RCT cut colorectal cancer incidence but missed its mortality target — exposing a design flaw that should...
A Nature Medicine validation of PREVENT and SCORE2 across 6.4M individuals offers a blueprint for RWE methodology that FDA...
The Supreme Court's Loper Bright ruling is quietly dismantling FDA's deference-based regulatory hold over synthetic biology, and clinical programs...
