Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in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....
An FDA advisory committee on Monday unanimously supported the investigational drug donanemab for treating early Alzheimer's disease....
The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to support drug development....
Palo Alto, California-based biotechnology company Guardant Health has applied for US Food and Drug Administration approval of Shield, its blood test to screen for early signs of colorectal cancer, and on Thursday, a panel of expert advisers to the FDA gathered to discuss data on...
The U.S. Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer....
There has been a real push among the industry to improve diversity in trials. The FDA report shows diversity statistics from US trials....
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....
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....
