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

  • Shore to Please

    As this year is coming rapidly to a close, I thought it might be interesting to review the ten biggest announced projects since January: read more

  • The Dog Days of Summer

    As I write this in the middle of August, during an oppressively humid heat wave, the term “the dog days of summer” comes to mind. If you have never heard that term, it refers to the hottest, most stifling period of summer. Quite apropos, as we are currently experiencing a heat wave. But where did the term come from? 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