59% of Sites Are Losing Patients Before They Ever Screen — Here’s Where the Pipeline Actually Breaks
A new survey finds 59% of clinical trial sites lose eligible patients to process failures. Krishma Shah breaks down...
The Trial You Never Have to Run: How Simulation Is Rewriting Clinical Development Economics
Nature Reviews Drug Discovery's 2026 simulation-guided trial framework shows sponsors how digital modeling can cut sample sizes 13–23% and...
Compass Has Two Positive Phase 3 Trials. The FDA Has Final Guidance. So Why Does Psilocybin Still Feel Like a Gamble?
Compass Pathways' 39% six-month response rate and the FDA's final psychedelics guidance arrive together. The field looks ready. Look...
ILUVIEN Meets Primary Endpoints in Phase 4 Uveitis Trial at Six Months
ILUVIEN meets primary endpoints in Phase 4 uveitis trial, showing 31% reduction in retinal swelling and 3.6-letter visual acuity...
Mesoblast Completes Enrollment of 300 Patients in Rexlemestrocel-L Back Pain Trial
Mesoblast completes enrollment of 300 patients in its pivotal rexlemestrocel-L chronic low back pain trial, targeting mid-2027 data readout.
FDA Approves LEQEMBI IQLIK Subcutaneous Injection for Early Alzheimer’s
FDA approves LEQEMBI IQLIK subcutaneous injection for early Alzheimer's disease, enabling at-home self-administration without clinic infusions starting late Aug
Three Strikes, Same Deficiency: How Elevar Therapeutics Turned a Solvable Manufacturing Problem Into a Patient Crisis
Elevar Therapeutics received its third FDA CRL in two years for rivoceranib plus camrelizumab in liver cancer, each citing...
The 2024 McDonald Criteria’s Lancet Neurology Publication Signals a Mandatory Protocol Audit for Active MS Trials
The 2024 McDonald MS criteria raised diagnosis rates 28% and cut median time to diagnosis from 84 to 40...
The FDA’s Psychedelic Guidance Is Really a Study-Design Reckoning
The FDA's July 2026 psychedelic guidance is nonbinding on paper. In practice it tells psilocybin, LSD, and MDMA developers...
When Your CRO Merges Mid-Study, the Site Pays the Price
Caidya and Simbec-Orion's merger creates a 6-month operational danger zone for sites running active studies. Here's what sponsor clinops...