Rare Disease Day is held on the last day of February to raise awareness for rare diseases and address drug development ...

Oxana Iliach is a Senior Director of Regulatory Strategy at Certara (PA, USA), a biotech company that offers comprehensive solutions for transforming and accelerating drug development. In her spare ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

How innovative technologies like AI and gene editing are advancing rare disease drug discovery and development.

Medicine stands at a remarkable crossroads. The explosive growth in specialty drug development marks a new golden age of therapeutic innovation. In 1990 there were just 10 specialty drugs on the ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

Advances in cancer research have led to an increasing number and variety of cancer therapies in the development pipeline, but there are concerns that traditional processes for drug development, ...

This episode of Chromatography Life takes a closer look at the evolving landscape of synthetic peptide drugs - one of the most compelling frontiers in biopharmaceutical analysis. Joining us is Matt ...

As sponsors advanced more niche and personalized modalities, manufacturers were pushed to adopt holistic approaches to safety ...