Alterity's End-of-Phase 2 meeting secured FDA agreement on trial design, dosing, and endpoints for its pivotal ATH434 programme in multiple system atrophy.

The Paris-based biotech secured RMAT status for its CD22-targeting off-the-shelf CAR-T candidate in relapsed or refractory B-cell acute lymphoblastic

Elraglusib will be assessed alongside dinutuximab beta and chemotherapy in relapsed and refractory paediatric neuroblastoma across up to 60 international sites.

A peer-reviewed study in Critical Care Medicine found Ceribell's AI algorithm associates high seizure burden with a 3.4-fold rise in death

The Basel biotech has initiated SIRIUS, a Phase 2 COPD trial of its twice-yearly anti-TSLP antibody WIN378, alongside an ongoing asthma programme.

GI prophylaxis cut Grade 2+ diarrhoea and colitis from 55% to 10% in the GCC-targeted CAR T-cell trial for metastatic colorectal cancer.

All 12 patients in a UChicago Medicine pilot achieved insulin independence, with mean HbA1c of 5.4% and no severe hypoglycaemic episodes post-transplant.

RemeGen's telitacicept becomes the first approved therapy for Sjögren's disease in China, backed by Phase 3 data showing significant improvements on both ESSDAI

China's NMPA has conditionally approved telitacicept for IgAN, marking the fourth indication for the dual BAFF/APRIL inhibitor and its first kidney disease clearance.

The Iceland-based biosimilar specialist said the FDA has accepted its BLA for AVT16, a proposed interchangeable biosimilar to Takeda's Entyvio, for ulcerative colitis

Sparrow Pharmaceuticals reported statistically significant HbA1c and cholesterol reductions from a placebo-controlled trial, with larger benefits in cortisol-enriched

The combined company will operate as Treeline Biosciences, with over $900m in cash and three Phase 1 oncology programmes already under way.