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Predicting FDA approval using artificial intelligence

Researchers from the University of California San Diego School of Medicine have described a new approach that uses artificial intelligence […]

The FDA MyStudies app

Experts has developed a mobile application and secure patient data storage platform – FDA MyStudies – to address privacy, engagement […]

FDA staff back controversial Alzheimer’s drug

In a lengthy statement released on Wednesday, FDA staff appeared to endorse Biogen’s treatment for Alzheimer’s disease. If approved, this […]

FDA benefit-risk frameworks for drug approval

In a recent study published in Therapeutic Innovation and Regulatory Science, researchers conducted a systematic review of the decision factors […]

FDA releases list of evidence-based pharmacogenetic variants

Pharmacogenetics (PGx) is the study of how an individual’s genetic makeup affects their drug response and metabolism. An understanding of PGx could help clinicians make prescribing decisions and has the potential to be implemented in routine care worldwide. PGx has understandably been gaining traction and support, with pharmacogenomic elements being implemented into many international Genomic studies.

Early clinical trial data supports amivantamab against a rare lung cancer mutation

Lung cancer is one of the leading causes of cancer death among men and women in the US. One option […]

Real-world immunotherapy response in metastatic urothelial cancer

Contrary to prior clinical trials, researchers have revealed that metastatic urothelial cancer patients with fibroblast growth factor receptor (FGFR) mutations […]

Real-world analysis of a drug combination for malignant peritoneal mesothelioma

A recent phase II study used real-world evidence to assess responses to a combination treatment of atezolizumab and bevacizumab in […]

Are ‘virtual patients’ the future of clinical trials?

Researchers have demonstrated that an in-silico approach, using virtual patient data, was able to replicate clinical trial results and investigate […]

New Alzheimer’s Drug Data Issues

Earlier this week the U.S. Food and Drug Administration approved the first new treatment for Alzheimer’s disease in almost 20 […]