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. ...
Xanomeline and trospium chloride (Cobenfy) has no boxed warnings...
The FDA is intent on improving the enrollment of participants -- also known as "subjects" -- from underrepresented populations in clinical studies for drugs and devices....
The first non-injectable emergency treatment for allergies is anticipated to hit shelves following FDA approval of the Neffy epinephrine nasal spray. Neffy is a non-needle-based epinephrine treatment for anaphylaxis and other allergic reactions...
The US Food and Drug Administration has approved a blood test to be used for colorectal cancer screening among average-risk adults 45 and older....
Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies....
