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.

John and Dom introduce guest Brad Nawa (Alamar Biosciences) to explain the NULISA™ platform, an ultra-sensitive platform for protein quantitation that aims to outperform earlier “ultra-sensitive” tools that often didn’t translate well in practice. Brad notes the platform is still antibody/content-driven, but differentiates itself by reducing background through a dual-capture purification step and a nucleic-acid barcode/ligation readout, enabling scalable multiplexing (currently ~256-plex, with room to expand). They emphasize the fully automated ARGO™ HT system as a key advantage for minimizing operator variability and supporting strong instrument-to-instrument and lot-to-lot reproducibility. The discussion covers applications including biomarker discovery/monitoring, patient stratification, and PK/PD - especially when sample volume is limited or sensitivity is critical - and use across many matrices (plasma/serum/CSF, tissue lysates, vitreous humor, and dried blood/plasma spots with high recovery reported for most targets). They close by framing the future around building robust datasets for AI/meta-analysis, expanding therapeutic content (notably CNS/neurodegeneration, immunology, and cardiometabolic), and improving cloud software for pathway-level interpretation.“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. 

In the latest episode of the Weekly Bioanalysis podcast, Dom and John break down their biggest takeaways from the recent AAPS and EBF meetings, sharing what stood out across the scientific sessions, exhibition floors, and industry conversations. They discuss the major themes shaping bioanalysis right now, from emerging technologies to shifting regulatory expectations, and compare how each conference approached them. Our hosts also dive into evolving practices in biomarkers, immunogenicity, and complex modalities, highlighting where the field seems to be headed next. Finally, they offer candid reflections on the changing structure of professional communities and what that might mean for networking and scientific collaboration. It’s a wide-ranging, insider recap of two of the year’s most important events—well worth a listen for anyone tracking trends in bioanalytical science.“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.

In this episode, hosts Dom and John welcome Jason Hannah, Director of Marketing at KCAS Bio, to discuss the company’s strategy for navigating the 2025 global conference season. With major events like AAPS PharmSci 360 in the U.S. and the European Bioanalysis Forum (EBF) in Barcelona on the horizon, Jason explains how KCAS approaches each with a structured, three-phase plan: pre-show planning, on-site activation, and post-show follow-up. He highlights the differences between large, trade show–focused meetings like AAPS and more intimate, science-driven gatherings like EBF, noting how KCAS Bio tailors its engagement and messaging to fit each audience. The conversation offers a behind-the-scenes look at how marketing and scientific teams align to make every conference a coordinated effort to strengthen relationships and showcase KCAS Bio’s leadership across the bioanalytical industry.“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.

During episode #93 of The Weekly Bioanalysis, John and Dom welcome guest Chris Crean, founder/CEO of Xyzagen, who reflects on three decades in drug development and how the field has shifted from small molecules to today’s complex biologics, gene editing, and beyond. Chris explains how Xyzagen helps small, science-driven teams move faster by uniting early discovery “back-office” needs so studies are right-sized and decision-ready. He dives into modern PK design, showing how advances in LC-MS and immunoassays slash sample volumes and enable smarter rodent studies while preserving animal welfare. The conversation covers non-compartmental vs. modeling/simulation approaches and the practical toolset teams actually use plus when tissue distribution and ocular/CNS models matter. Chris also shares collaboration advice and highlights Xyzagen’s strengths in ophthalmology, neurology, and specialized routes like intrathecal or intravitreal dosing.“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.

During episode #92 of The Weekly Bioanalysis, our hosts, John and Dom, dive into GLP-1 receptor agonists—originally developed for type 2 diabetes—and how their mechanisms (stimulating insulin, slowing gastric emptying, and reducing glucagon) also drive significant weight-loss effects. They discuss why native GLP-1 is too short-lived to be therapeutic and outline engineering strategies that extend half-life (e.g., fatty-acid albumin binding or Fc-fusion), walking through approved agents like exenatide, liraglutide, dulaglutide, lixisenatide, semaglutide, and tirzepatide (a dual GIP/GLP-1 agonist). Our hosts note bioanalytical implications of peptide size and structure, and common outcomes/side effects such as appetite suppression and occasional GI symptoms or nausea. We are excited to welcome John’s wife. Catherine, to the podcast for the first time. She joins to highlight her experiences and the real-world benefits of her GLP-1 treatments. The conversation closes by framing these drugs less as “weight-loss meds” and more as tools for broader metabolic health, with growing research and potential future indications.“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.

In episode #91 of The Weekly Bioanalysis, John and Dom return to a two-person format to tackle the "gray areas" of bioanalysis, focusing on drug discovery, biomarkers, tissues, and emerging technologies. They discuss how traditional PK assay validation is highly standardized, but areas like early-stage discovery, biomarker qualification, and tissue analysis require more nuanced, fit-for-purpose approaches. A key theme is the need for flexibility and client collaboration, particularly when defining what constitutes validation versus qualification. The hosts emphasize how evolving technologies and commercially available reagents are enabling more streamlined, context-driven assays, though terminology differences—especially between U.S. and EU practices—continue to cause confusion. They close with a discussion on tissue assay limitations, particularly the inherent variability introduced during sample homogenization.“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.

In this episode of “The Weekly Bioanalysis” podcast, our hosts, Dominic Warrino and John Perkins, sit down with two key leaders shaping the company’s future — Maria Nelson, Chief Financial Officer, and Julie Deane, Chief People Officer — to discuss KCAS Bio’s strategy for balancing rapid growth with an exceptional employee experience. Building on the previous conversation with Jeff Goddard, this episode dives deeper into how KCAS Bio has evolved its people operations and operational planning. Julie shares how private equity investment fueled a transformation in talent acquisition, creating a scalable, high-performing recruitment process that attracts thousands of candidates monthly while enhancing the KCAS Bio employer brand. Meanwhile, Maria explains the company’s internal forecasting model, CURE (Capacity Utilization Resource Evaluation), which enables proactive workforce planning to meet client demands without compromising efficiency. Together, they reveal how KCAS Bio blends scientific excellence with business strategy to grow responsibly and maintain its strong culture.“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.

In Episode 89 of The Weekly Bioanalysis, hosts Dominic Warrino and John Perkins engage in a compelling conversation with special guest, Jeff Goddard, Senior Vice President of Corporate Development at KCAS Bio. The three delve into KCAS Bio's strategic growth, including the acquisition of France-based Active Biomarkers, which expanded the company's transatlantic presence. Jeff shares insights into the evolving landscape of bioanalytical services and how KCAS Bio is positioning itself to meet the challenges of modern drug development. The discussion also touches on the importance of collaboration and innovation in accelerating therapeutic discoveries.“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.

In Episode 88 of The Weekly Bioanalysis, hosts Dominic Warrino and John Perkins present a special WRIB 2025 recap featuring several KCAS Bio scientists who share firsthand insights from their presentations at the major bioanalytical conference. Dave Ambrose highlights KCAS Bio’s global harmonization of spectral flow cytometry instruments across sites in the U.S., France, and Australia, showcasing the industry’s first off-the-shelf spectral flow panel with impressively tight inter-site CVs. Jessica Pham discusses her work on a VAMS-based PK assay for an anti-malarial monoclonal antibody, designed to enable microsampling in remote regions with high temperature stability. Bryan Parmentier presents a novel method for overcoming matrix effects in cisplatin assays by adding exogenous hemoglobin, a breakthrough inspired by clinical anemia observations. The episode concludes with a group discussion about the implications of new biomarker guidance from the FDA and ICH M10, sparking debate on validation standards, regulatory interpretations, and industry alignment.“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.