Created in 1992, the FDA's accelerated approval pathway allows an initial approval of drugs for serious or life-threatening ...

With its active pharmaceutical ingredient (API) facility “in a state of disrepair,” manufacturer Aspen Biopharma Labs’ operations have ground to a halt in the U.S., according to a recent FDA reprim | ...

The Johns Hopkins surgeon will helm the agency as layoffs loom and important decisions on treatments for rare and infectious diseases await.

Despite the uncertainty currently sweeping through the Food and Drug Administration, President Donald Trump’s pick to lead ...

The integration of AI and cloud technologies is transforming pharmaceutical manufacturing regulations, focusing on safety, efficiency, and global harmonization.

vTv Therapeutics, a biopharmaceutical company based in High Point, has received clearance from the U.S. Food and Drug ...

The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...

On December 18, 2024, the Company announced the submission of its 510 (k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent ...

Ernst emphasized the strategic transformation of Tivic into a diversified therapeutics company, combining biologic and bioelectronic approaches to address immune dysregulation. This includes ...

While AI adoption in GMP settings is still evolving, regulatory agencies emphasize explainability and validation of AI models ...

A team of undergraduate researchers has developed an innovative way to produce essential medications more affordably and ...