EMA's ACT EU advice pilot becomes permanent in January 2027, giving EU sponsors consolidated multi-country feedback before CTA submission. Here's what ...

Clinical data teams now prioritize AI validation and human oversight in regulatory workflows, following FDA guidance on ...

Patient-owned health data model reduces clinical trial recruitment redundancy by enabling persistent consent and longitudinal ...

Tenax pauses LEVEL-2 enrollment to refine TNX-103 patient selection after the initial trial missed its primary walking ...

FDA approves Tecentriq for stage III dMMR colon cancer as adjuvant treatment. ATOMIC trial showed improved disease-free survival when added to chemotherapy.

Sionna advances SION-451/SION-2222 combo into Phase 2a trial for cystic fibrosis, building on insights from prior SION-719 ...

Xilio Therapeutics announced initial positive Phase 2 data for vilastobart (XTX101), a tumor-activated anti-CTLA-4 antibody, combined with atezolizumab (Tecentriq®) in patients with metastatic ...

Ribo files EU Trial Application for RBD3133, an siRNA targeting INHBE for obesity treatment backed by human genetic evidence.

FDA approves Rhapsido (remibrutinib) for symptomatic dermographism, the first prescription treatment for adults with the ...

Remibrutinib reduces relapse rates versus teriflunomide in Phase 3 MS trials REMODEL-1 and REMODEL-2, with results presented ...

Jupiter Neurosciences doses first Parkinson's patient in JOTROL Phase 2a trial, testing whether enhanced resveratrol achieves ...

Picture a conference room in Basel or Cambridge or South San Francisco in early 2025. A chief scientific officer clicks to slide three of her investor deck: a timeline graphic showing AI compressing ...