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...
The Two-Fisted Antibody: What the 10E8.4/iMab Phase 1 Trial Teaches Us About Designing for Complexity
A Nature Medicine phase 1 trial of bispecific HIV antibody 10E8.4/iMab shows how partially randomized adaptive design handles dual-mechanism...
$7 Billion Into AI Drug Discovery and Zero Approved Drugs: The Industry Is Funding the Wrong Race
$7B committed to AI drug discovery, zero approved drugs. The real bottleneck is clinical development—and the capital hasn't caught...
The Patients We’ve Been Afraid to Treat: PTSD, Psychosis, and What the STAR Trial Just Proved
The STAR trial enrolled 305 psychosis-PTSD patients clinicians long excluded from trauma therapy. The safety and efficacy data should...
TG Therapeutics Launches Phase 2 Trial of BRIUMVI in Treatment-Resistant Schizophrenia
TG Therapeutics launches Phase 2 trial of BRIUMVI in treatment-resistant schizophrenia, testing an anti-CD20 therapy approved for MS in...
Genzyme Ireland’s 483 Is Not a Manufacturing Story. It’s a Sponsor Oversight Indictment.
FDA's June 2026 warning letter to Genzyme Ireland over Altuviiio manufacturing exposes how post-approval CGMP oversight collapses at the...
AMO Pharma Aligns With FDA, MHRA, Health Canada on AMO-02 Study Design for cDM1
AMO Pharma aligns with FDA, MHRA, and Health Canada on AMO-02 study design, selecting hospitalization as the primary efficacy...