Phathom Fills 95 Patients in a Disease With No Approved PPI: What the pHalcon-EoE-201 Enrollment Speed Reveals
Phathom enrolled 95 EoE patients across 41 U.S. sites ahead of schedule — in a disease where PPIs dominate...
Auvelity’s Approval Just Rewrote the Rules for Dementia Agitation Trials
FDA approved Auvelity (dextromethorphan/bupropion) for Alzheimer's agitation with Breakthrough Therapy status, setting a new evidence bar for CNS behavioral…
Gene Therapy Just Delivered Dopamine Directly Into the Brain. Now Comes the Hard Part.
BBM-P002's Phase 1 data in 10 Parkinson's patients shows dual-target AAV gene therapy can restore dopamine synthesis. The FDA...
Ten Years of EMA Post-Authorization Data Reveal a System Running on Incomplete Evidence
A Nature Reviews Drug Discovery analysis of EMA post-authorization studies exposes systematic gaps in how conditional approvals convert to...
China’s Tenecteplase Trial Just Challenged the Global Stroke Playbook — and the FDA Should Be Paying Attention
A phase 3 RCT from China finds tenecteplase before EVT cuts disability in proximal MCA occlusion strokes 4.5–24 hrs...
The Neurodegenerative Trial Problem Has a Design Solution—But Sponsors Keep Ignoring It
MAMS platform trials could slash neurodegenerative drug development timelines—so why are sponsors still running serial Phase 2s for Alzheimer's...
The Cancer Nobody Saw Coming: What One Gene Therapy Tumor Tells Us About a Broken Safety Surveillance System
A rare gene therapy-linked cancer case exposes fatal gaps in long-term safety monitoring—and why FDA's 15-year follow-up mandate isn't...
Europe’s 2030 Clinical Trial Targets Are Already Falling Behind — And the Clock Is Ticking
EMA's first 2026 quarterly report shows only 40.5% of EU trials recruiting within 200 days — far below the...
Favipiravir Just Beat Ribavirin in Lassa Fever—Now Comes the Hard Part
A Phase 2 RCT published in Nature Medicine shows favipiravir cut Lassa fever mortality with HR 0.50—but the regulatory...
Digoxin’s Second Chance Just Ran Out: What a Failed Phase 3 RCT Reveals About Cardiovascular Drug Development
Low-dose digoxin cut hospitalizations but missed its primary endpoint in a 1,400-patient RCT—exposing a gap between statistical significance and...