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 ...

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

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

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

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

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

Biopharma quality control is being revolutionized by advanced analytics and digital transformation through a synergy that ...

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 ...

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