IDMP standards aim to improve medicinal product data management but have faced delays, limiting their benefits for the life ...

Johnson & Johnson’s Tecvayli (teclistamab-cqyv), used in combination with daratumumab to treat relapsed or refractory multiple myeloma, has received FDA’s latest national priority voucher, becoming ...

Life sciences is a decade behind other industries in its optimization and strategic exploitation of data. This is perplexing, given how much companies profess their ambitions to exploit AI. An ...

Traditional solid-phase oligonucleotide synthesis is hitting its limits as demand for RNA therapeutics surges. Enzyme-enabled RNA synthesis offers a scalable, sustainable alternative — and leading ...

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

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 ...

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

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

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

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

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