The science behind the first pig-organ transplant trial in humans
A clinical trial will help to establish whether kidneys from genetically modified pigs can be transplanted into people safely and effectively....
A clinical trial will help to establish whether kidneys from genetically modified pigs can be transplanted into people safely and effectively....
The US Food and Drug Administration signed off on the first new type of pain reliever to be approved in more than two decades....
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson's (JNJ.N), nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the company said on Tuesday....
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions....
The recently proposed U.S. Food and Drug Administration (FDA) guidance updated the agency’s expectations for the contents of informed consent forms for clinical trial participants. ...
After the Food and Drug Administration’s recent decision to delay the approval of MDMA-assisted therapy for post-traumatic stress disorder, the path forward has become less straightforward for the field of psychedelic medicines....
The drug is a 24-hour infusion injected below the skin that treats motor fluctuations in patients with advanced Parkinsons....
Two experts on regulatory and compliance trends weigh in on the FDA's recently issued guidance on decentralized clinical trials....
A review of the FDA's regulation of artificial intelligence (AI) and the potential uses of AI in medical product development, clinical research, and clinical care....
Wisconsin scientists are among those conducting dozens of clinical trials worldwide on the use of psilocybin to treat depression. They say the evidence shows that, in combination with therapy, it shows great promise. ...