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 ...
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 ...
Acne research has lacked a genuinely novel oral mechanism for decades, which makes the FDA’s August 13, 2026 clearance of Sagimet Biosciences’ Investigational New Drug application for denifanstat a ...
Inhibrx Biosciences is running a two-program sprint on $219.5 million in cash, a number that includes a freshly drawn $100 million tranche from Oxford Finance, and the next 90 days will determine ...