A marketed drug has three names: a chemical name, a generic name, and a brand name. A chemical name is given when a new chemical entity (NCE) is developed. The chemical name is a scientific name based ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

Instil Bio, Inc. announced the clearance of an Investigational New Drug (IND) application for its drug AXN-2510 by the FDA, enabling the company to begin a phase 1 trial before the end of 2025. This ...