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The Operational Foundations That Characterize Regulatory Leaders
Holding individuals and teams explicitly accountable for data accuracy and quality might seem straightforward, but it is difficult to sustain in practice. read more
Horizon Lines: A Quarterly Review of NDAs – January-March, 2026
The NDAs approved during the first quarter of 2026 have been divided into the dosage forms Injection, Tablets, Capsules, Oral solution, Gas, and other. read more
The Human Advantage in ADME Testing
Animal models do not accurately recapitulate several aspects of human physiology, and these differences lead to variations in drug behaviors across species. Each contributes useful evidence, but what is missing is the connected human biology needed to predict ADME behavior with confidence. read more
An Interview with Rod Ketner, PhD
Sponsors sometimes optimize too narrowly for the next milestone instead of the full development path. A formulation may be sufficient for an early study but still be poorly positioned for robust scale-up, transfer, or validation. That’s where delays and added costs show up. read more

Clinical Trials - Transforming Drug Development
Transforming Drug Development: Accelerating Clinical Trials through Patient-Centric Innovations and Technological Breakthroughs Watch Now

MedPharm Signs First-to-File Generic Topical Supply Deal
Tuesday, November 10, 2026
MedPharm has added a first-to-file generic topical product to its commercial manufacturing portfolio. Under the agreement, MedPharm will serve as the ... read more
Evonik Produces First Lipids at New Indiana Center
Tuesday, November 10, 2026
Evonik has manufactured the first batch of GMP-quality pharmaceutical lipids at its new Lipid Innovation Center in Lafayette, Indiana. The large-scale... read more
NAMSA, Advanced Medical Solutions Form Partnership
Tuesday, November 10, 2026
NAMSA and Advanced Medical Solutions (AMS) have entered into a preferred partnership to accelerate the development and commercialization of AMS's ... read more
Simtra Opens $250M+ Bloomington Expansion
Tuesday, November 10, 2026
Simtra BioPharma Solutions has opened Building H, a more than $250 million expansion of its Bloomington, Indiana manufacturing campus. The CDMO, ... read more
PharmaLogic to Acquire Lantheus CDMO Business
Tuesday, November 10, 2026
PharmaLogic Holdings has signed a definitive agreement to acquire the CDMO business and Springfield, New Jersey manufacturing facility from Lantheus ... read more