New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...

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

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

The pharmaceutical contract manufacturing market is driven by increased outsourcing of complex processes to CMOs, enabling ...

Adam Kovalčík showed off a poster about his research at the Regeneron International Science and Engineering Fair in Columbus, Ohio.Chris Ayers Photography/Licensed by Society for Science When Adam ...

What is Pharma 4.0? The term Industry 4.0 refers to the fourth industrial revolution, associated with the application of advanced technologies that have dramatically changed the landscape of ...

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, ...

Pharmacy benefit managers received substantial attention during 2024. Congress and regulating agencies including the FTC and HHS scrutinized PBM business practices and related profits. As a new ...

Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...

Space-based drug labs are here! See how Varda and United Therapeutics are using microgravity to improve rare lung disease ...