For how we live.
The patented method uses mifepristone for hypercortisolism-related insulin resistance, with dosing capped to avoid over-activating the stress-hormone axis. The public can object before the deal closes.
A draft replacing a 2003 document would extend hepatic-impairment dosing studies to biologic drugs and to drug effects, not just blood levels. It is open for comment before the agency finalises it.
Lorecivivint improved pain modestly and changed nothing structural. Sprifermin grew cartilage and the effect made no difference by year five. Both illustrate the gap between a biomarker and a benefit.
Two 2026 reviews make the case that human-derived models can replace animal testing. A third paper argues the field is checking the biology and the algorithm separately, and calling that assurance.
Buntanetap showed dose-dependent cognitive benefit in biomarker-positive patients with mild disease. The company's announcement does not say what happened in the full 351-patient population.
The agency says it has been relaxing chemistry and manufacturing expectations for cell and gene therapies case by case. The change is that every sponsor now knows it.