Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...

The process of drug development can lengthy and complex, with multiple stages and regulatory requirements to be met. In the United States, the Food and Drug Administration (FDA) is responsible for ...

FDA proposals include ‘major updates’ to simplify biosimilarity studies, reduce unnecessary clinical testing, and ease the process for making biosimilars interchangeable with brand-name biologics.

The U.S. drug development process for novel therapeutics targeting difficult-to-treat diseases takes an average of 10 to 12 years to complete. For drugs that go into development this year, that ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

Khoshsokhan, Sina. The Costs They Are a-Rising: Commercialization Costs and the Innovation Process in Drug Development. Academy of Management Annual Meeting Proceedings. 2024, Vol. 2024 Issue 1, p1-6.

With new technologies that allow drugs to be tested directly in human biological systems, researchers are beginning to ...

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 ...

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

The pharmaceutical industry widely uses antibodies to create drugs, such as for cancer and coronaviruses. But creating the proteins using computers has been a long-standing challenge in drug design.