Cat’s-claw, chaparral, and blue-green algae (spirulina) supplements for rheumatoid arthritis may do more harm than good.

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

Xuewu Liu, a Chinese inventor who has no medical training or credentials of any kind, is charging cancer patients $20,000 for ...

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...

Bypassing its standard pathways for scientific discussions, FDA has recently held a slew of so-called "expert panels" that ...

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

The FDA's 'Elsa' AI, intended to speed up drug approvals, is reportedly fabricating studies, part of a wider trend of ...