Unlike the dopplegängers of folklore or the evil twins of popular entertainment, digital twins don’t just appear seemingly out of nowhere. They are painstakingly developed and refined. And neither are ...

When we treat cancer patients, their disease can overcome treatment through its innate capacity to adapt. This is at the ...

Technical Report No. 56 (Revised 2026) outlines a GMP--compliant, phase--appropriate quality management system (QMS) spanning preclinical development through clinical phases and commercial readiness ...

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 ...

In 2022, the combined research and development (R&D) expenditure of the U.S. pharmaceutical industry consisted of more than $100 billion. While this is a significantly expansive market, approximately ...

Opinions expressed by Digital Journal contributors are their own. Bringing a new biologic drug from concept to clinic is a complex journey fraught with technical and regulatory hurdles. For ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

The process of discovering new drugs and bringing them to market is notoriously slow and inefficient. Amazon Web Services is hoping to use AI to streamline this process, it announced Tuesday. Amazon ...

(CNN) — The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...