Candida, a type of fungus, can spread throughout the body via the bloodstream, leading to organ damage and sepsis. Recently, ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...

Would you get a one-time genetic modification such that you'd never have to take a GLP-1 drug for weight loss ever again?

One of the biggest obstacles in cancer treatment is drug resistance in cancer cells. Conventional efforts have focused on ...

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...

Weight-loss drugs have surged in popularity, promising rapid results with regular injections. Now, researchers from Japan ...

The Canadian government is currently considering approving the entry of gene-edited pigs into the food system.

The FDA granted orphan drug designation to Sineugene Therapeutics' SNUG01, a first-in-class experimental gene therapy for ...

The potential of gene therapies will only be realized if the manufacturing challenges can be resolved, and that’s a tricky ...

Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...

Technology can be harnessed to design novel and enhanced molecules that address challenges in biotechnology or medicine.