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.

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

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.

Now, with the European Union Health Technology Assessment (HTA) regulation coming into force as part of the required Joint Clinical Assessment (JCA) for oncology and advanced therapy medicinal ...

The author presents lessons from the front lines of oncology, rare disease, and cell and gene therapy submissions.

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 ...

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 ...