• Horizon Lines: A Quarterly Review of NDAs – July-September 2025

    This quarterly review on New Drug Applications contains data for applications approved during the third quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 48 applications were approved by the FDA during these three months. read more
  • Future-Proofing Pharmacovigilance in an AI Era

    Clinical research organizations (CROs) are entering an era in which pharmacovigilance systems are doing more than just tracking copious amounts of data. They must also keep pace with evolving regulations, manage the growing volume of adverse event reports, and respond to heightened scrutiny from both regulators and the public. read more
  • Limitations of Existing Life Science Software - and the Opportunity to Evolve

    ELNs, LIMS and SDMS systems aren’t going away anytime soon. They provide a foundation for doing reliable, collaborative, and impactful science. The key here is that by embracing and adopting new technologies, scientific organizations can protect their existing investments while unlocking new levels of efficiency, collaboration, and discovery - at their own pace and on their own terms. read more
  • Sustaining the Future of Life Science Product Research

    Few people say it outright, but the integrity of stored research and clinical samples underpins all scientific and medical progress. Every breakthrough drug, advanced therapy, or medical device depends on millions of biological, chemical, and physical samples that must be preserved intact across the entire product lifecycle. read more