The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. Through the program, sponsors are given a “Meeting ...

Judge Pauline Newman has served with distinction on the U.S. Court of Appeals for the Federal Circuit since her appointment ...

The Inflation Reduction Act (IRA) of 2022 mandates price negotiations for certain drugs under Medicare, shortening the exclusivity period historically used to recoup research and development ...

Instead of requiring personalized gene edits for each patient, the new approach could create a standardized method to use for ...

“The best ideas in drug discovery were often blocked not by biology, but by synthesis,” Boiko told TechCrunch. Synthesis is ...

The shift towards sustainability in drug development focuses on reducing lab waste and enhancing operational efficiency for a ...

A spokesperson for the FDA said the agency is “considering a wide range of options to support American innovation." ...

New clinical trial results presented by TB Alliance at the Union World Conference on Lung Health show that the novel antibiotic candidate sorfequiline (TBAJ-876), a next-generation diarylquinoline, ...

With new technologies that allow drugs to be tested directly in human biological systems, researchers are beginning to ...

How People, Process, and Systems Transform the Business of Life Sciences” by Gary K. Zammit, PhD, is released with Forbes ...

Lonza helps biotech firms accelerate from DNA to IND with tailored strategies that reduce risk and speed complex biologics to ...

Researchers at the University created an AI model called EZSpecificity to test how certain enzymes and substrates bind to ...