In today's ACT Brief, we explore organizational factors behind CRL decisions, methodological concerns with pooling amyloid ...

He closed by identifying governance and review cycle inertia as the most underappreciated execution risk in an AI-accelerated ...

Biomarkers are redefining how oncology trials are designed, shifting from single-mutation targeting to comprehensive genomic ...

Passage Bio initiated a strategic review process after regulators didn't support a single-arm trial design for its dementia drug. The Food and Drug Administration indicated a randomized controlled ...

Clinical site selection platform RyghtAI has launched a search engine designed to give drug developers and contract research ...

In April 2026, Replimune Group received a complete response letter from the FDA for its BLA seeking approval of RP1 plus nivolumab for advanced melanoma, despite earlier breakthrough therapy ...

Health care is undergoing an important and well-needed shift from a one-size-fits-all approach to more personalized, precise, patient-focused care. A similar approach needs to be implemented at scale ...

Clinical trials are notoriously expensive, time consuming, and risky. Failure comes at a very high cost (millions of dollars and months of development time wasted), yet studies show that the rate of ...

Cantargia AB (Publ) (Nasdaq Stockholm:CANTA) today reported that the rationale and study design of the phase 1b/2 clinical trial investigating nadunolimab in combination with immune-checkpoint ...

Adaptive clinical trial design represents a modern approach to evaluating healthcare interventions that allows pre‐specified modifications based on accumulating data. This flexible methodology ...