Featured Editorial
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Beyond GalNAc: Reengineering siRNA For Extrahepatic Delivery
9/9/2026
We discuss why effective extrahepatic delivery remains one of the field's biggest obstacles and how chemical engineering may provide a new path forward.
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Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases
9/4/2026
Targeted lipid nanoparticles (LNPs) could deliver mRNA encoding a CAR directly to T cells inside a patient with allergic disease. The potential implications extend beyond a single allergic condition.
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The Future Of Cancer Drug Discovery Is Targeted Immune Activation
9/2/2026
Using targeted delivery systems to generate therapeutic agents directly within tumors has implications for how oncology drugs are discovered and developed.
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Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations
9/1/2026
In this article, consultant Doug Mead reports on precedent research he conducted into FDA databases on 21 CFR Subpart cGMPs for combination products. His observations and conclusions offer sound advice on how to approach summaries submitted for BLA and NDA purposes.
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Unpacking The FDA Draft Guidance On Container Closure Systems
8/26/2026
In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
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Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
8/26/2026
How can sponsors revive a promising modality with known safety limits? Vast Therapeutics CEO Nate Stasko, Ph.D., explains how ALX1 is reshaping nitric oxide delivery.
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Why Delivery Is Defining The Next Era Of Neuromuscular Therapeutics
8/19/2026
Emerging therapies are being designed to safely deliver oligonucleotides to disease-relevant tissues. Delivery is no longer a technical hurdle to overcome but a strategic lever.
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Inquiries In Inhalation, Part 2: Having A Nose For Innovation
8/19/2026
In this follow-up article, Chief Editor Tom von Gunden extends his Part 1 discussion of therapeutic targets for inhaled drugs and biologics into specific aspects of delivery innovation. Among the key considerations are particle engineering, device usability, and the coordination across the ecosystem of inhalation delivery design, development, and distribution. The coverage of advances in device technologies includes inhalers, nebulizers, and nasal sprays.
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Inquiries In Inhalation, Part 1: The Breadth Of Breath
8/12/2026
In this article, Chief Editor Tom von Gunden considers the expanding range of addressable targets for inhalation drug and biologics delivery. He reports on innovations in oral and nasal inhalation technology that enhance approaches to traditional respiratory indications, as well enable delivery of inhaled therapies to systemic targets beyond the nose and lungs.
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PLGA: A Workhorse Polymer Behind Modern Depot Long-Acting Injectables
8/7/2026
PLGA-based long-acting injectables drive sustained drug delivery, with advances in generics, depot technologies, and manufacturing expanding patient access and innovation.