FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requirements to publicly repo...
A panel of industry leaders, policy experts, and FDA say broader adoption of external control arms in oncology drug development will depend on improve...
FDA cites an Indian drug manufacturer for deficiencies in laboratory testing and quality control procedures following an inspection conducted in Decem...
FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBERs next director.
FDA accepts for priority review a Daiichi Sankyo and Merck BLA for ifinatamab deruxtecan, an investigational therapy for patients with advanced small ...
FDA cites Pfizer over social media promotions for its cancer drug Adcetris, stating that certain Facebook advertisements are false or misleading.
A new policy analysis from the Cato Institute urges FDA to modernize its regulatory framework for artificial intelligence in healthcare.
FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for ad...
