There’s no doubt that large language models and generative AI tools have taken the world by storm. Their ability to create, ...

There has been much discussion recently about how artificial intelligence and machine learning (AI/ML) will revolutionize pharmaceutical research. Substantial progress has been made in the discovery ...

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 ...

A major step toward simpler drug development has been taken at the University of Gothenburg. In a new study, researchers have developed stable boron-fluorine compounds that make it possible to ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...

The development of new medication by biotech and pharmaceutical companies, from target identification to marketing approval, is a time-consuming process with timelines extending to 12 years or more.

It’s always a high-stakes gamble in the pharmaceutical industry to develop a new drug. The process typically takes 10 to 15 years and requires extensive testing, regulatory approval, and clinical ...

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 FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

In a year from now, progress is to be measured in the institutionalisation of the approach with greater regulatory acceptance ...