The CNPV program significantly reduces drug review times, necessitating operational shifts for sponsors to meet compressed ...

Jonathan Haigh, Head of UK Sites, FUJIFILM Biotechnologies, explores how advanced technologies are being used to reduce risk ...

A long-term, trust-based CDMO partnership can support cell and gene therapy developers from early process development through ...

In Episode 30, John Androsavich, Benjamin Fryer, and John Wilkerson go behind the headlines. Behind the Headlines examines ...

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

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 ...

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 ...

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 ...