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 ...

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

The EU pharmaceutical reform aims to improve drug accessibility, affordability, and innovation, addressing market protection and antimicrobial resistance. Co-legislators in Europe have reached a ...

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

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