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 ...

The FDA has released draft guidance on how sponsors can use Bayesian models for clinical trials.

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.

As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more ...

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, ...

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

Thanks to modern therapies, a cancer diagnosis is no longer an automatic death sentence. But many patients still suffer from unwanted side effects and limited efficacy. In a recent Bioconjugate ...