FDA report highlights need to improve diversity in clinical trials
There has been a real push among the industry to improve diversity in trials. The FDA report shows diversity statistics from US trials....
16 May, 2024
FDA
FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer
Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer....
24 April, 2024
FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease
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....
22 March, 2024
Patient overcomes metastatic prostate cancer thanks to clinical trial
UW Carbone Cancer Center patient Gary Davey struggled with metastatic prostate cancer until a clinical trial brought new hope....
19 February, 2024
FDA facilitates AI and ML use for clinical trials and drug development
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....
13 February, 2024
Clinical trials: FDA proposes new standards for collecting race, ethnicity data
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a standardized approach for collecting and reporting on race and ethnicity data in clinical trials and studies in a new draft guidance document....
30 January, 2024
FDA issues final guidance on rare disease drug development
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....
09 January, 2024
UW-Madison study investigating treatment to prevent Alzheimer’s disease
A research study at UW–Madison School of Medicine and Public Health is investigating a drug that could one day prevent Alzheimer’s disease....
17 November, 2023
From the Outside In: An Overview of Four Decades of Progress on HIV/AIDS
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-...
17 October, 2023
Faster drug approvals by FDA raise concerns about transparency and beneficence in clinical trials
Are faster drug approvals by the FDA hurting the public's overall perception of clinical research?...
30 August, 2023