FDA extended its denecimig BLA review over unnamed facility remediation failures, exposing the manufacturing blind spot that nearly every...

A dual-cohort Lancet Psychiatry study links CYP2D6 poor metabolizer status to venlafaxine treatment failure, pressing sponsors to rethink IND...

Headlands Research Portland site marks 50 years of continuous Alzheimer's trials, contributing to every FDA-approved medication class since 1993.

Advarra's IRB chief targets pre-review delays as the next efficiency frontier to reduce waiting time for researchers and trial...

Forward Therapeutics' FT2109 advances to Phase 2 after clearing Phase 1 with once-daily oral dosing and a supportive safety...

Coya Therapeutics completes enrollment of 120 patients in COYA 302 ALS trial testing an immunomodulatory approach to slow neuroinflammation.

Lu AF28996 gains over 2 hours of daily ON-time in Parkinson's Phase Ib trial, with meaningful reductions in troublesome...

Jon Himoff, Chief Product Officer of Image Analysis Group (IAG), on why purpose-built imaging platforms outperform assembled toolkits in...

A pilot RCT links psilocybin's 25 mg dose to reduced egocentric bias in alcohol use disorder, exposing a blind...

First-in-human trial targets the amygdala with focused ultrasound in MDD, raising hard questions about biomarker selection, endpoint design, and...