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 ...

SYCUME met its Phase 3 primary endpoint for inactive thyroid eye disease, showing significant proptosis reduction versus ...

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 ...

Clearside Biomedical announced positive results from a meeting with the FDA regarding its Phase 3 clinical trial plans for CLS-AX, a treatment for wet age-related macular degeneration (wet AMD). The ...

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 ...

CinFina Pharma, a CinRx portfolio company focused on obesity treatments, has released promising interim data from a Phase 1 single ascending dose (SAD) study of CIN-110 and final data from a multiple ...

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 ...