Happy New Year: Review of New Drug Approvals in 2025

In episode #97 of “The Weekly Bioanalysis” podcast, John and Dom focus on a review of 2025 drug approvals, revealing a surprisingly strong year for small molecules despite long-standing predictions of their decline. Of the 53 FDA approvals, 31 were small molecules, with additional complexity coming from ADCs and RNAi therapies, underscoring the continued importance of small-molecule development and analytics. The hosts also compare U.S. and European approvals, noting meaningful differences driven by regulatory timing and regional priorities rather than scientific divergence. They highlight encouraging momentum in ADCs, the role of acquisitions in successful approvals, and a broad mix of indications—from rare diseases and oncology to neurology and vaccines. Overall, the episode reinforces that innovation remains diverse, with small molecules, large molecules, and conjugated technologies all playing critical roles in modern drug development. If you want a comprehensive view of the noteworthy approvals from 2025, this is the episode you’re looking for!“The Weekly Bioanalysis” is a podcast dedicated to discussing bioanalytical news, tools and services related to the pharmaceutical, biopharmaceutical and biomarker industries. Every month, KCAS Bio will bring you another 60 minutes (or so) of friendly banter between our two finest Senior Scientific Advisors as they chat over coffee and discuss what they’ve learned about the bioanalytical world the past couple of weeks. “The Weekly Bioanalysis” is brought to you by KCAS Bio.KCAS Bio is a progressive growing contract research organization of well over 250 talented and dedicated individuals with growing operations in Kansas City, Doylestown, PA, and Lyon, France, where we are committed to serving our clients and improving health worldwide. Our experienced scientists provide stand-alone bioanalytical services to the pharmaceutical, biopharmaceutical, animal health and medical device industries.