FDA has granted orphan drug designation to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary ...

Facility design should integrate risk mitigation strategies, focusing on contamination prevention and reliable utility ...

FDA announced on Dec. 1, 2025 that it will be providing agency staff with agentic artificial intelligence (AI) capabilities ...

Advanced technologies in pharma manufacturing necessitate a redefinition of the Qualified Person's role, focusing on digital ...

Several European biotechs, including Cellbox Labs, Evotec SE, Nanolive SA, and Salipro Biotech AB, have developed innovative ...

Qualified Person eligible and experienced in QA/Operations with 15 years leading pharmaceutical manufacturing, quality assurance, and regulatory compliance across global markets. Proven track record ...

Several 3D printing technologies are currently considered more clinically applicable, including SSE, fused deposition ...

The first patient visit has taken place for the SURMOUNT-REAL UK clinical trial of Eli Lilly and Company’s weight-loss drug, tirzepatide.

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

Gain leadership and innovation insights from CEO of the Year finalist at 2025 CPHI Pharma Awards, Mahler Hanns-Christian, who ...

Artificial intelligence (AI) and machine learning (ML) tools offer an ultra-material-sparing approach to accelerate ...

This session will explore best practices for sourcing and managing comparator products in clinical trials. It is designed to ...