News

Theriva's VCN-01 Phase 2a trial in Spain aims to test more frequent dosing in metastatic pancreatic cancer and evaluate...

Givinostat extended ambulation to median age 17.3 years in DMD patients, with quantitative MRI data showing preserved muscle tissue...

FDA confirms single Phase 3 trial sufficient for ATH434 NDA in Multiple System Atrophy, backed by Phase 2 evidence.

Agios wins FDA Priority Review for mitapivat in sickle cell disease with November 2026 PDUFA date, targeting transfusion-free outcomes...

EMA expedites daraxonrasib review for metastatic pancreatic cancer with orphan designation and priority pathway status following Phase 3 trial...

TG Therapeutics launches Phase 2 trial of BRIUMVI in treatment-resistant schizophrenia, testing an anti-CD20 therapy approved for MS in...

AMO Pharma aligns with FDA, MHRA, and Health Canada on AMO-02 study design, selecting hospitalization as the primary efficacy...

FDA adopts ICH E6(R3) guidance, redistributing trial accountability across sponsors, sites, and vendors with new data governance requirements.

Clinical trial software market expands beyond large sponsors, reaching $900M in 2024 with SaaS deployment enabling smaller research sites...

Ascletis files two IND applications for once-monthly obesity drugs targeting three receptors with a single injection, showing 51% greater...