One of the reasons why rare disease, medications take so long to get to the clinic is because we have very specific ...

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 ...

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

From antibiotic resistance to emerging viral threats, the global demand for new medicines is intensifying, yet traditional drug discovery pipelines remain slow and expensive. A new scientific review ...

Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...

The FDA has released draft guidance on how sponsors can use Bayesian models for clinical trials.

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors, and the general public. Researchers have ...

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 ...

In this forward-looking whitepaper, Blue Mountain explores how agentic AI —autonomous, context-aware AI agents—could ...