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 ...

AI’s true promise is turning clinical development from a bottleneck into a throughput engine for human health. Drug discovery ...

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 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 ...

Medicine stands at a remarkable crossroads. The explosive growth in specialty drug development marks a new golden age of therapeutic innovation. In 1990 there were just 10 specialty drugs on the ...

Generative AI adoption, regulatory scrutiny, DEI policy shifts, real-world evidence, and rare disease economics emerged as key themes across these most-read Applied Clinical Trials articles shaping ...

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 ...

BOSTON--(BUSINESS WIRE)--PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced that it has developed several new solutions that take a ...

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 ...

The Trump administration's funding cuts to PEPFAR and USAID disrupted global HIV treatment and prevention, threatening progress made over decades. Lenacapavir's FDA approval as a long-acting ...