Latest Articles

  • 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

  • Horizon Lines: A Quarterly Review of NDAs – April to June 2026

    This quarterly review on New Drug Applications contains data for applications approved for the first time during the second quarter of 2026, which includes New Molecular Entities (NMEs) and new biologics. read more

  • The Tough Decisions

    While there are many drugs to make the end of life easier and less painful, the fundamental problem of deciding when to end life is a topic and a decision few want to address. read more