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...
FDA Accepts BridgeBio’s Encaleret NDA for Autosomal Dominant Hypocalcemia Type 1
FDA accepts BridgeBio's Encaleret NDA for autosomal dominant hypocalcemia type 1, with PDUFA review set for May 2027.
When the Consent Form Is the Catastrophe: What Alembic’s FDA Warning Letter Means for Your Site
Alembic's July 2026 FDA warning letter on informed consent failures at its Vadodara BE facility exposes the GCP documentation...
The 2-Week Window: What a Phase 1 iPSC Trial Teaches Us About Designing Cell Therapy Studies That Can Actually Win Approval
A Nature Medicine phase 1 iPSC neural progenitor trial in subacute spinal cord injury shows how to build the...
Armata Submits Phase 3 Protocol for AP-SA02 Bacteriophage in S. aureus Bacteremia
Armata Pharmaceuticals submits Phase 3 protocol for AP-SA02 bacteriophage targeting S. aureus bacteremia, with trial launch planned for late...
The Informed Consent Warning Letter Every Site Director Should Read Twice
FDA's July 2026 warning letter to Alembic's bioequivalence site exposes informed consent failures that can ground any trial. Here's...
Healx Doses First Patient in HLX-4310 Trial for Metastatic Osteosarcoma
Healx doses first patient in HLX-4310 trial for metastatic osteosarcoma, targeting micro-metastatic dormancy in relapsed and refractory cases.
Agios Discontinues Tebapivat Development in Sickle Cell Disease
Agios discontinues tebapivat development in sickle cell disease after Phase 2 showed no meaningful separation from placebo.