George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...

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 ...

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

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

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

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 ...

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

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

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 ...

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