Setmelanotide Phase 3 Trial for Hypothalamic Obesity Published in NEJM
Setmelanotide Phase 3 Trial achieves 19.8 percentage-point BMI reduction in hypothalamic obesity, published in NEJM following FDA approval.
When Two CROs Become One, Sites Pay the Integration Tax
Caidya and Simbec-Orion's June 2026 merger creates real site-level friction: dual CTMS logins, monitoring model gaps, and budget renegotiations...
FDA Accepts Arcutis ZORYVE Application for Atopic Dermatitis in 3-Month-Old Infants
FDA accepts Arcutis ZORYVE for atopic dermatitis in 3-month-old infants, expanding treatment options for the youngest patients with the...
The Fentanyl Vaccine Is Real. The Evidence Strategy Isn’t.
ARMR Sciences' fentanyl vaccine entered Phase 1 in January 2026 with 40 participants. The science is credible. The path...
Theriva Gets Spain Approval for VCN-01 Phase 2a Trial in Pancreatic Cancer
Theriva's VCN-01 Phase 2a trial in Spain aims to test more frequent dosing in metastatic pancreatic cancer and evaluate...
Givinostat Shows Extended Ambulation in DMD Patients, MRI Data Released
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 MSA
FDA confirms single Phase 3 trial sufficient for ATH434 NDA in Multiple System Atrophy, backed by Phase 2 evidence.
Agios Wins Priority Review for Mitapivat in Sickle Cell Disease
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
EMA expedites daraxonrasib review for metastatic pancreatic cancer with orphan designation and priority pathway status following Phase 3 trial...
The $10B Integration Problem Vertex Hasn’t Solved Yet
Vertex's $10B Crinetics acquisition doubles its therapeutic footprint overnight. Here's what that means for site contracts, CTMS consolidation, and...