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 my previous article, I discussed how AI is rapidly transforming the drug discovery process, significantly accelerating timelines and reducing costs. However, while AI's potential in this domain is ...

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 ...

The pharmaceutical industry is experiencing its own “DeepSeek moment,” according to science writer Hiya Jain. Just as the upstart AI breakthrough caught Silicon Valley off-guard, China is emerging as ...

Global rare disease policy shifts are reshaping orphan drug development, with major implications for equitable access in the UK, EU and US.

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

Additions to sites in Cincinnati, Ohio, and Bend, Ore. broaden early development capabilities to help accelerate pre-clinical oral drug product innovation and advanced drug delivery CINCINNATI & BEND, ...

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