Latest Articles

  • Horizon Lines: A Quarterly Review of NDAs – October- December 2025

    This quarterly review of New Drug Applications contains data for applications approved for the first time during the last quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 40 applications were approved by the FDA during these three months. read more

  • How AI is Transforming Clinical Trials

    AI is already reshaping the clinical trials industry and that transformation looks set to continue over the next five years. New technologies will enable the development of more personalized medicines, empower more responsive trial designs and improve informed decision making by unlocking new data insights. read more

  • Flexibility as a Core IND Strategy

    With the increasing complexities of current IND programs, it is critical to work with regulatory agencies to seek input early in the process. read more

  • Rethinking the Oligonucleotide Journey

    The history of oligonucleotide therapeutics illustrates that transformative medical progress occurs when foundational scientific breakthroughs are matched by equally robust advances in development infrastructure. Over the next decade, oligonucleotides are poised to expand their clinical footprint beyond reactive treatment and toward proactive preventive intervention for highly prevalent chronic conditions. read more