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....
04 February, 2025
FDA
FDA approves first new type of pain medication in 25 years
The US Food and Drug Administration signed off on the first new type of pain reliever to be approved in more than two decades....
03 February, 2025
FDA approves standalone use of J&J’s ketamine-derived depression treatment
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....
21 January, 2025
FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions....
02 January, 2025
New Informed Consent Expectations Should Aid Participants’ Understanding, May Catch Professionals Off Guard
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. ...
21 November, 2024
What’s Next for Psychedelic Medicines?
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....
30 October, 2024
Injectable drug to ease advanced Parkinson’s disease symptoms approved by FDA
The drug is a 24-hour infusion injected below the skin that treats motor fluctuations in patients with advanced Parkinsons....
17 October, 2024
Decentralized clinical trials back in the spotlight thanks to new FDA guidance
Two experts on regulatory and compliance trends weigh in on the FDA's recently issued guidance on decentralized clinical trials....
16 October, 2024
FDA perspective on the regulation of artificial intelligence in health care and biomedicine
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....
15 October, 2024
Wisconsin is on the front lines of psychedelic research that could reach millions
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. ...
07 October, 2024