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

  • Hasty Decisions, Runaway Projects

    Despite the best intentions of ISO and EMA, the pharma industry is still largely failing to exploit its data in a strategic, joined-up way - and this could now restrict companies’ ability to capitalize on AI. read more

  • Under the Spotlight: Agentic AI

    In an interview with Pharmaceutical Outsourcing, ArisGlobal’s Jason Bryant discusses the premise of AI’s next high-profile incarnation, the technology’s potential in late-stage pharma R&D operations, emerging early use cases, and some of the guardrails that need to be in place to ensure trusted, impactful use. read more

  • An Interview With Franco Negron

    Simtra’s capability to support high-volume injectables and lower-volume modalities provides balanced expertise across the sterile injectables landscape. read more