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 ...

3D printing enables personalized precise drug delivery, enhances compounding efficiency, and is driving new regulatory models like distributed pharmaceutical manufacturing.

Pharmaceutical Technology | Publications | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.

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