As pipelines across modalities diversify, regulatory scrutiny intensifies, and the margin for error in development execution continues to shrink, partnering with a CDMO has never been more critical.

Cancer drug development has never moved faster. Yet, for too many patients, the next treatment decision still begins with ...

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 ...

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 ...

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 ...

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 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.

The Food and Drug Administration’s (FDA’s) breakthrough therapy designation (BTD) program was created to increase patient access to safe and effective therapies by supporting the efficient clinical ...

Getting a clearer picture of the true costs and risks of drug research and development is a critical starting point in ensuring a more balanced and accurate policy approach toward biomedical ...