In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for ...

Neurodegenerative disorders are characterized by complex neurobiological changes that are reflected in biomarker alterations detectable in blood, cerebrospinal fluid (CSF) and with brain imaging. As ...

Interest in biomarkers has exploded in recent years, driven by improvements in data collection and analysis, burgeoning interest in personalized medicine, and efforts to increase the success rate for ...

While agents like AbbVie's Humira have transformed the treatment landscape, not all patients benefit equally from the drug.

Protein biomarkers increasingly play a vital role in advancing health research, driving drug development, and improving clinical outcomes. The close connection between protein biomarkers and human ...

Drug development involves significant risk and expense. With average development costs topping $1 billion per approved medicine and stubbornly high failure rates, pharmaceutical leaders are ...

Every decision in drug development carries weight. The right biomarker insights can make those decisions more confident and data-driven. In this white paper, experts from AstraZeneca, Johnson & ...

Despite their importance, a significant number of biomarker strategies fail because they are added too late, are not feasible in real clinical settings, or are poorly aligned with clinical endpoints.

Predictive biomarkers to guide selection of first-line chemotherapy for advanced pancreatic ductal adenocarcinoma (PDAC) are an unmet clinical need. This study used the Computational Histology ...

Accurate non-invasive biomarkers to diagnose metabolic dysfunction-associated steatotic liver disease (MASLD)-related fibrosis are urgently needed. This study applies a translational approach to ...