Compass Pathways Just Answered the Durability Question. Now Comes the Harder Problem.
Compass Pathways' 52-week COMP360 data shows 40-45% response rates in treatment-resistant depression. FDA approval in 2027 means nothing without...
FDA Approval
Lecanemab’s At-Home Start Dose Just Rewrote the Rules for Alzheimer’s Trial Design
FDA's July 2026 approval of at-home subcutaneous lecanemab initiation eliminates the 18-month IV requirement, reshaping CNS trial recruitment and...
Psilocybin Has Crossed the Evidence Threshold. Clinical Guidelines Have Not.
Compass Pathways' Phase 3 six-month data and a first-ever psilocybin-PTSD veteran trial signal readiness — but the guideline infrastructure...
Auvelity’s Approval Just Rewrote the Rules for Dementia Agitation Trials
FDA approved Auvelity (dextromethorphan/bupropion) for Alzheimer's agitation with Breakthrough Therapy status, setting a new evidence bar for CNS behavioral…
The GLP-1 Pill Just Broke Every Obesity Trial Playbook
The FDA's approval of oral orforglipron for obesity isn't just a formulation win — it's a structural disruption to...