Latest Articles

  • 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

  • Quality: The Gold Standard for CDMOs - No Exceptions, No Compromises

    In today’s hyper-competitive pharmaceutical landscape, innovation, speed-to-market and cost control usually take the spotlight when selecting a contract development and manufacturing organization (CDMO). However, underneath all those metrics, a single truth remains: if quality fails, so does everything else. read more

  • Why Pharma AI Projects Fail: The Human Problem Behind Technical Success

    Artificial intelligence (AI) is one of the most talked-about tools in the pharmaceutical world, not because of hype, but because of its practical potential. But repeatedly, promising projects stall - or outright fail - not because the models are wrong or the data is flawed, but because people simply don’t use the tools. read more

  • How Tariffs Could Impact Your Drug Development Supply Chain: Top Five Things to Be Aware Of

    The pharmaceutical industry is entering a period of intensified trade disruption. With new tariffs on imported raw materials, active pharmaceutical ingredients (APIs), and medical components, global supply chains that once prioritized efficiency are now facing rising costs, increased complexity, and growing regulatory risk. For companies developing biologics and Antibody-drug conjugates (ADCs), the impact is particularly acute. read more