Operating under the FDA's 503B pathway, the Apex facility will prioritize the production of generic shortage-listed ...

USP is developing digital reference standards to integrate into modern digital environments, enhancing regulatory confidence ...

Katalyze AI today announced the launch of Katalyst, an AI agent purpose-built for pharmaceutical manufacturing. Designed for ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

The most immediate impact of AI is felt in the research phase, where the timeline for designing molecules has shrunk from ...

The U.S. Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education a grant worth up to $35 million over the next five years to improve drug ...

A CDMO championing a commitment to patients may sound like lip service or branding, but truly patient-centric CDMOs offer ...

From the moment we could look up to the skies, humanity has dreamt of what’s up there. And once we got there, how could we master it? And now that we’re there all the time, how can we use it? In 2025, ...