Unanimous Thumbs-Up From FDA Advisors for Alzheimer’s Drug
An FDA advisory committee on Monday unanimously supported the investigational drug donanemab for treating early Alzheimer's disease....
10 June, 2024
FDA
FDA plans to release AI drug development guidance this year
The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to support drug development....
30 May, 2024
Blood test to detect colon cancer could move a step closer to FDA approval in the US
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...
24 May, 2024
FDA Approves New Drug for Deadly Lung Cancer
The U.S. Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer....
17 May, 2024
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 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