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 DSCSA Compliance in 2026 Hinges on Execution, Not Implementation

    After a decade of ramp-up, the era of DSCSA enforcement is no longer theoretical — it’s here. But as we move deeper into this phase of full compliance, the real story unfolds not just in establishing data feeds, but in the operational cracks that persist behind the scenes. read more

  • PV Automation Next Steps: Solving the Significant Headache of Local Literature Monitoring

    Medical literature monitoring is a key part of pharmacovigilance (PV) and ultimately patient safety across the lifecycle of a medicine. Globally, the practice is relatively straightforward, but up to now, screening local literature has been a highly resource-intensive activity yielding modest, if vital, findings. That smart automation might alleviate the burden comes as a huge relief, especially as product development ambitions grow and PV process innovation becomes essential to control costs. Biologit’s Jean Redmond explains. read more