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 ...
Tiffanwy Klippel-Cooper of OmnigeniQ explains how physics-based modelling could help researchers better understand drug ...
PDA Publishes Revised Technical Report No. 56: A Clear, Phase Appropriate Roadmap for GMP Compliant Development of Biological Drug Substances Technical Report No. 56 (Revised 2026) outlines a ...
In the last few years, multispecific antibodies, such as bispecific, trispecific, and tetraspecific antibodies, have become the breakthrough stars in antibody therapeutics. Compared with conventional ...
Find out how self-driving labs utilise data-driven approaches to enhance drug discovery efficiency and innovation.
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 ...
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 ...
Artificial intelligence (AI) has been revolutionizing much of early drug discovery, yet human clinical trials remain a bottleneck. Now some applications of the new technologies are bringing ...
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FDA to streamline approvals for generic biological drugs in latest move targeting health costs
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 accelerate ...
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