The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union.

The European Union (EU) reform establishes a regulatory data and market protection period of eight years, capped at 11 years ...

The CNPV pilot program approved its first drug, an amoxicillin-clavulanate potassium antibiotic, in two months, enhancing domestic manufacturing and national security. Augmentin XR, combining ...

Indivumed, of Hamburg, Germany, is no stranger to cancer-centered collaborations; in August 2021, the company announced a ...

GMPs require high cleanliness and maintenance standards to prevent contamination and ensure product quality in pharmaceutical ...

Sanner, a company that offers sustainable packaging products and contract development and manufacturing services, announced ...

When referring to this article, please cite it as Hennessy, M. How Innovation and Risk Management Are Reshaping Modern Drug ...

Counterfeit pharmaceuticals jeopardize public health worldwide, often leading to ineffective or dangerous treatments. Enter ...

The EU pharmaceutical reform aims to improve drug accessibility, affordability, and innovation, addressing market protection and antimicrobial resistance. Co-legislators in Europe have reached a ...

Novartis agrees to acquire Avidity Biosciences, an innovator in RNA therapeutics, strengthening its late-stage neuroscience ...

The biannual AustinPx Amorphous Solid Dispersions (ASD) Workshop is a place for collaboration and innovation. Hear firsthand ...

Several European biotechs, including Cellbox Labs, Evotec SE, Nanolive SA, and Salipro Biotech AB, have developed innovative ...