Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease....
UW Carbone Cancer Center patient Gary Davey struggled with metastatic prostate cancer until a clinical trial brought new hope....
The US Food and Drug Administration (FDA) is focusing on how artificial intelligence (AI) can be used to support clinical trials but says it will take time to get there....
The US Food and Drug Administration (FDA) is outlining a standardized approach for collecting and reporting on race and ethnicity data in clinical trials and studies in a new draft guidance document....
The US Food and Drug Administration (FDA) finalized guidance on drug development programs for rare diseases, eliminating a section on natural history and providing additional considerations related to patient and caregiver input and pediatric populations....
A research study at UW–Madison School of Medicine and Public Health is investigating a drug that could one day prevent Alzheimer’s disease....
New clinical treatments for diseases are conceived in a laboratory, then tested on animals or through simulations, and finally studied on human beings if deemed promising enough. Moving from point to point in this cycle is rarely a straight line, and costly and time-consuming trial-and-...
Are faster drug approvals by the FDA hurting the public's overall perception of clinical research?...
Commenters on the FDA's guidance on clinical investigations and drug development programs for psychedelic drugs raised concerns about decoupling drug administration from psychotherapy support, the proposed credentials for lead safety monitors and the agency’s characterization of the abuse potential of psychedelic drugs....
n a recent Clinical Leader Live! episode hosted by Life Science Leader Chief Editor Ben Comer, clinical trial experts Mitchell Katz, SVP, global clinical operations at Kyowa Kirin; Jessica Powell, VP, clinical operations at Alto Neuroscience; and Michael Krams, chief quantitative medicine officer at Exscientia,...
