Oncology drug and biologics developers received new guidance on setting limits for endotoxins during the clinical trial process, in the form of a draft document from the US Food and Drug ...

The US Food and Drug Administration (FDA) recently issued a warning letter to TEI Biosciences, a unit of Integra LifeSciences, for releasing collagen-based products which failed bacterial endotoxin ...

A recent guidance update from the U.S. Food and Drug Administration (FDA) on pyrogen and endotoxins testing represents a missed opportunity to meaningfully advance alternatives to horseshoe-crab-blood ...

New standards may help push more drugmakers to use a synthetic product for critical drug safety testing, instead of one made from horseshoe crab blood that has long drawn criticism. The U.S.

Surf on a beach at sunset features a horseshoe crab upside down in the water and several others nearby. Regulatory changes may make the pharmaceutical industry less reliant on horseshoe crabs for ...

Novel Approach to Achieving Consistent Results with the Limulus Amebocyte Lysate Test The standard tool for screening endotoxins—highly toxic, heat-stable lipopolysaccharides that constitute the outer ...