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The FDA has released draft guidance on how sponsors can use Bayesian models for clinical trials.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

Developing a new medication can cost over $1 billion, depending on the drug’s complexity and expenses accrued via unsuccessful studies. Considering these costs, an optimized regulatory process is ...

Creating a new drug involves significant time, effort, and resources. Many assume drug development is straightforward, with final products approved fairly quickly, but the drug approval timeline can ...

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, ...

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

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 ...