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 ...

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 ...

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 ...

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

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 ...