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 ...

The FDA has released draft guidance on how sponsors can use Bayesian models for clinical trials.

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

This article summarizes a discussion at LSX Biopharm America on September 11. A panel of industry experts discussed approaches to overcoming the most urgent CMC challenges during the discussion. The ...

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, ...

Duxin Sun receives funding from the NIH, FDA, and pharmaceutical industries including Bristol-Myers Squibb, Celgene Corporation, Aurinia Pharmaceuticals, Abbvie, Nanomedicine Innovation Center.

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

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