The LITMUS Study Just Changed How You Should Design Your MASLD Trial Endpoints
LITMUS Imaging Study validates imaging and serum biomarkers for MASLD fibrosis—here's what it means for endpoint strategy in your...
CHMP Recommends Marketing Authorization for Obicetrapib in EU
CHMP recommends marketing authorization for obicetrapib in the EU, with Phase 3 trials showing up to 50% LDL-C reductions...
FDA Approves LYTENAVA, First Ophthalmic Bevacizumab for Wet AMD
FDA approves LYTENAVA, the first ophthalmic bevacizumab formulation for wet AMD, ending two decades of off-label use in retina...
The Inherited Retinal Disease Trial That Should Change How Sponsors Think About AI Diagnostic Evidence
A multicenter RCT in Nature Medicine just validated AI-based IRD diagnosis—and exposed a gaping hole in how the FDA...
Laminar Pharma Completes LAM561 Phase 2b/3 Trial in Glioblastoma
Laminar Pharma's LAM561 Phase 2b/3 trial in glioblastoma completes enrollment with topline overall survival data expected in Q2 2027.
Genmab, AbbVie Clarify Epcoritamab Phase 3 Trial Missed Primary Endpoint
Genmab and AbbVie clarify that epcoritamab Phase 3 trial missed primary endpoint for overall survival in transplant-ineligible DLBCL patients.
Atsena Gets EMA Orphan Status for ATSN-101 and ATSN-201
Atsena receives EMA orphan status for ATSN-101 and ATSN-201, with Phase 3 trials already underway for rare retinal diseases.
The Hybrid Vaccine Trial Design That Could Render Pure RCTs Obsolete
A landmark NEJM editorial argues combining RCT and observational data can unlock vaccine effectiveness insights no single design can...
Venus Medtech Completes Enrollment in PREVAILS TAVR Trial for Venus-PowerX
Venus Medtech completes enrollment in PREVAILS TAVR trial for Venus-PowerX, a retrievable aortic valve targeting CE marking and NMPA...
LB Pharmaceuticals Accelerates NOVA-2 Schizophrenia Trial Readout
LB Pharmaceuticals accelerates readout from NOVA-2 schizophrenia trial of LB-102, signaling confidence in the Phase 3 data package ahead...