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 ...

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

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 ...

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

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 ...

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 ...