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 ...

Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive ...

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 & ...

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 ...

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

ViewsML, a company building the computational layer for biomarker discovery by transforming tissue analysis from a lab process into software, today announced the completion of an oversubscribed $4.9M ...

Regulators remain cautious about adopting biomarkers as surrogate endpoints for drug approvals, despite industry calls for faster integration. While the FDA and CMS have launched the RAPID pathway to ...

Please provide your email address to receive an email when new articles are posted on . ADx NeuroSciences and Alamar Biosciences have announced a partnership to develop customized biomarker assays for ...

Key market opportunities in the CNS Biomarkers sector include utilizing AI and technologies like ML and NLP to enhance drug ...