New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

How today’s manufacturers are filling the growing need for biologics without rushing complex processes in development or ...

The Food and Drug Administration (FDA) is launching a new program to ramp up the United States’s domestic pharmaceutical supply chain, the agency announced Thursday. The program, called FDA PreCheck, ...

The London-based company said its in-space microgravity crystallization process could enable cancer treatment to be delivered ...

Scientists have developed a new strategy to enhance pharmaceutical production in Chinese hamster ovary (CHO) cells, which are commonly used to manufacture protein-based drugs for treating cancer, ...

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 ...

After positive momentum on the plan in late 2025, European Union lawmakers have taken a critical step toward implementing a ...

President Donald Trump signed an executive order to incentivize drug manufacturing in the U.S. The order comes ahead of Trump's planned tariffs on pharmaceuticals imported into the U.S. U.S.