Some drugs may seem like they were named by throwing darts at the alphabet – but the process of drug naming is actually very intentional. In an interview with Fox News Digital, Dr. Dave Latshaw, CEO ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

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 ...

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.

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 ...

OPKO Health is refocusing on drug development, with most pipeline assets in early stages and limited near-term catalysts.