A therapy under development at the University of Wisconsin School of Medicine and Public Health to treat a common side effect of radiation therapy recently got a boost from the Food and Drug Administration....
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....
