Patient-centric evidence, such as PROs and RWE, offers insights into patients' needs, enhancing drug development beyond traditional endpoints. Challenges include increased complexity and regulatory ...

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 ...

FDA proposals include ‘major updates’ to simplify biosimilarity studies, reduce unnecessary clinical testing, and ease the ...

Judge Pauline Newman has served with distinction on the U.S. Court of Appeals for the Federal Circuit since her appointment ...

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.

We are living in a dynamic time of drug development and innovation with many beneficiaries—the most important being the patient. These developments include everything from exciting gene therapies for ...

Drug discovery has traditionally been slow and expensive, often taking decades and costing manufacturers billions. Traditional methods, while advancing, are hitting limits in tackling the complexities ...

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 ...