New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported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, ...
Adam Kovalčík, age 19, innovated a cheaper, faster way to produce an antiviral drug. Galidesivir targets RNA viruses like COVID-19, Ebola, and Zika but hasn't completed clinical trials. Kovalčík won a ...
As biologics have come to supersede small molecules in the biopharma industry’s pipeline, the mounting complexity behind the ...
Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...
Lakewood-Amedex Biotherapeutics Inc., (NASDAQ: LABT, the "Company"), a clinical-stage biotechnology company advancing a novel ...
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 ...
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 ...
Pharmaceutical manufacturing encompasses all processes involved in the manufacturing and production of biological and medical products, botanical drugs, and herbs, as well as other pharmaceutical ...