New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported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

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.

Artificial intelligence continues stirring things up in chemistry. To wit: Y Combinator-backed Cambridge, U.K.-based ReactWise is using AI to speed up chemical manufacturing — a key step in bringing ...

The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while ...

Regulatory approval is a major milestone in the drug development process, but it is not the final chapter in the journey.

President Trump wants pharmaceutical production to return to the United States. A shuttered factory in Louisiana shows how hard that will be for generic medicines. Dr. Reddy’s, an Indian generic ...

Advancements in drug manufacturing technologies are reshaping global regulatory frameworks. This shift is largely driven by the integration of artificial intelligence (AI)-powered models, cloud-based ...

This investment comes as LGM Pharma experiences sustained growth in prescription drug projects, including 505(b)(2) and Abbreviated New Drug Application (ANDA) programs. The Rosenberg facility ...

Amid an outpouring of industry investments in U.S. drug production, the FDA has launched a new program designed to significantly reduce the complexities involved in setting up domestic manufacturing ...