Latest Articles

  • Engaging with Regulators for Single-Arm Oncology Research Trials

    When well-planned and well-executed, single-arm trials can accelerate access to life-saving therapies that might otherwise never reach desperate cancer patients. read more

  • From Lunar Orbit to First in Human: The High Stakes of Bold Science

    Much like the literal moonshots now back on the launch calendar, first in human studies are defined by the tension between danger and possibility. They are where bold ideas either earn the right to move forward or are stopped before they can do more harm than good. As an industry, our challenge is to keep reaching for those transformative rewards while taking the risks - scientific, financial, and human - every bit as seriously as a crew strapping in for a flight around the Moon. read more

  • HPLC-Based Strategies for Impurity Profiling and Validation in Standard Drug Analysis

    The control of pharmaceutical impurities is a fundamental objective in the development of drugs, focusing on the comprehension of the chemical structures of unidentified impurities. This understanding is essential for evaluating toxicological consequences and grasping the mechanisms of formation. API-related impurities, such as degradation and interaction, can affect drug product quality, safety, and efficacy. Classifying sources of impurities is essential for analytical method development and acceptance criteria. read more

  • 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