On Dec. 19, 2025, Emer Cooke, executive director of the European Medicines Agency (EMA), published highlights of the agency’s accomplishments in 2025, which marked three decades since its inception.

Dr. Eva-Maria Hempe, NVIDIA, looks back at 2025 and ahead to 2026, noting that AI accelerates pharma overall, particularly in ...

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried ...

Britton Jimenez, SVP of Sales and Marketing at Codexis, explains how the ECO Synthesis® Manufacturing Platform overcomes the ...

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

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 ...

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

Mandy Vink, VP of Business Development at Codexis, explains how the company leverages over 20 years of expertise in small-molecule APIs to advance biocatalysis across pharma.

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

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

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