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.
AI-Designed Drugs Are Reaching Human Trials. Now Comes the Hard Part.
Healx's HLX-4310 Phase 1/2 trial in osteosarcoma shows AI drug discovery maturing—but adaptive dose-escalation in adolescent oncology exposes trial...
IMUNON’s IMNN-001 Shows Lower Residual Disease in Phase 2 Ovarian Cancer Study
IMNN-001 demonstrated lower residual disease rates versus control in Phase 2 ovarian cancer study, with 44% showing disease at...
GLP-1 Agonists Are Quietly Reducing Addiction Hospitalizations, But Only While Patients Take Them
A Lancet Psychiatry study shows GLP-1 agonists cut AUD and SUD hospitalizations, but the protection fades after stopping —...