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

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

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

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

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 ...

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 ...

The FDA Commissioner’s National Priority Voucher pilot program has added J&J’s Tecvayli as the latest voucher recipient.

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

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 ...

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

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 European Union (EU) reform establishes a regulatory data and market protection period of eight years, capped at 11 years ...