Barzolvolimab meets all primary and key secondary endpoints in Phase 3 CSU trials, advancing Celldex's mast cell-targeting ...

Roche's sefaxersen Phase 3 IgAN study met its primary endpoint, significantly reducing proteinuria versus placebo at 37 weeks ...

Vistagen's fasedienol shows positive results in open-label extension for social anxiety disorder, following two Phase 3 ...

CBL-514 meets primary endpoint in Phase 2 Dercum's Disease trial, with 90% of patients achieving meaningful pain relief at ...

Tekton Research launches dedicated psychiatry team across 17 sites to address rater drift, diagnostic variability, and participant dropout in psychiatric trials ...

FDA's 2026 shift to a single pivotal trial as the default approval standard forces sponsors to rethink Phase 3 design before the next IND meeting.

Merry Life Biomedical starts Phase 2 trial of TML-6, an oral drug targeting autophagy-lysosomal pathways in early Alzheimer's ...

Ivonescimab plus chemotherapy achieved a statistically significant overall survival benefit over durvalumab in biliary tract ...

Radial's FDA-cleared Evoke EEG integration across 27 brain medicine clinics tests whether distributed neuroimaging endpoints ...

Phase III Clinical Trials now generate 5.9M data points annually with 11% yearly growth, raising questions about managing ...

Roche's enicepatide met Phase II endpoints in type 2 diabetes trial, demonstrating dose-dependent reductions in HbA1c and body weight over 48 weeks.

FDA Part 11 Compliance requires validated systems, audit trails, and electronic signatures linked to individual users. Learn ...