Capricor’s Duchenne AdCom Didn’t Fail on Science. It Failed on Statistics.
FDA's CTGTAC voted 9-3 against Capricor's deramiocel on July 30, 2026. The science wasn't the problem. The statistical methodology...
The FDA Measures All Schizophrenia Symptoms at the Same Clock. A Six-Trial IPD Analysis Just Proved That’s Wrong.
A Lancet Psychiatry IPD meta-analysis of six antipsychotic trials shows hostility resolves weeks before negative symptoms—exposing a critical flaw...
Adlai Nortye Wins HREC Approval for AN4035 Pan-RAS ADC Phase I Trial
Adlai Nortye wins HREC approval for AN4035 Phase I Trial, a CEACAM5-targeting ADC with pan-RAS inhibitor payload entering human...
AXPAXLI Shows 72% Reduction in Injection Burden vs Aflibercept in Wet AMD
AXPAXLI reduces injection burden by 72% versus aflibercept in wet AMD, based on Phase 3 SOL-1 trial analysis.
Opus Genetics Completes Enrollment in OPGx-LCA5 Phase 3 Trial
Opus Genetics completes enrollment in OPGx-LCA5 Phase 3 trial for rare inherited retinal disease, with dosing starting Q4 2026.
Nurix Starts Phase 3 Trial of Bexobrutideg Against Pirtobrutinib in CLL
Nurix launches Phase 3 trial of bexobrutideg against pirtobrutinib in relapsed/refractory chronic lymphocytic leukemia with dual primary endpoints.
GLP-1 Agonists Reduce AUD Hospitalizations — But Stopping Them Is a Clinical Decision We’re Not Ready For
Lancet Psychiatry data show GLP-1 agonists cut AUD hospitalizations, with protection lasting 182 days post-discontinuation. Here's what that means...
Your GBA1 Enrollment Plan Is Built for European Sites — And That’s a Problem
Lancet Neurology data shows <4% of Parkinson's genetic trials enroll non-European patients. Here's what ops teams must fix before...
The Recruiter in the Frame: What a Danish RSV Trial Reveals About Who Gets to Invite You Into a Study
A nested trial inside DAN-RSV found that video presenter sex affects adult enrollment decisions, exposing a mechanism most protocol...
Mesoblast’s Ryoncil Posts $115M First-Year Revenue on Pediatric Approval
Mesoblast's Ryoncil generated $115M in first-year revenue following FDA approval for pediatric SR-aGvHD, with Q4 reaching $36M.