FDA Approves Lilly’s EBGLYSS for Every-Eight-Week Dosing in Atopic Dermatitis
FDA approves every-eight-week dosing for Lilly's EBGLYSS in atopic dermatitis, reducing injections to six per year for adults and...
When Your CRO Gets Acquired Mid-Trial, the Site Pays the Operational Price
Tevogen Bio's MSO/CRO acquisition push signals a consolidation wave that will disrupt site activation, monitoring, and contracts mid-study. Here's...
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...
Psychedelic Trials Are Producing Stunning Numbers. The Methodology Underneath Them May Not Hold.
Luvesilocin's 70% PPD remission rate and psilocybin-CBT pilot data are turning heads—but sex-specific blind spots and a therapy model...
Zynlonta’s 3-to-1 Death Ratio Is the Accelerated Approval System Grading Its Own Homework
ADC Therapeutics' LOTIS-5 trial shows 13.2% fatal events vs. 4.6% in controls—a 3:1 death imbalance that exposes accelerated approval's...
The EMPHASIS Trial Correspondence Surfaces Three Trial Design Constraints That Will Shape the Next Neuroprotection Protocol
A Lancet correspondence on EMPHASIS identifies patient selection limits, generalisability gaps, and statistical design issues that every stroke trial...
Alkeus Starts Phase 3 Trial of Gildeuretinol for Stargardt Disease
Alkeus starts Phase 3 NORTHSTAR trial of gildeuretinol for Stargardt disease, enrolling 230 patients across 55 sites in 11...
Ambros Starts CRPS-RISE Phase 3 Trial of Neridronate for Complex Regional Pain Syndrome
Ambros launches CRPS-RISE Phase 3 trial of neridronate for complex regional pain syndrome, enrolling 270 patients with warm-phase CRPS-1.
Potravitug Shows Improved Viral Clearance in BKPyV Kidney Transplant Trial
Potravitug shows improved viral clearance in BKPyV kidney transplant trial, with 64% achieving one-log reduction by week 20 versus...
When the Manufacturing Site Fails, Your Enrollment Plan Fails With It
Novo Nordisk's Bloomington facility hit with another FDA 483 — here's how manufacturing findings cascade into site enrollment holds,...