FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBERs next director.
FDA cites Pfizer over social media promotions for its cancer drug Adcetris, stating that certain Facebook advertisements are false or misleading.
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 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 new policy analysis from the Cato Institute urges FDA to modernize its regulatory framework for artificial intelligence in healthcare.
FDA cites an Indian drug manufacturer for deficiencies in laboratory testing and quality control procedures following an inspection conducted in Decem...
FDA accepts for priority review a Daiichi Sankyo and Merck BLA for ifinatamab deruxtecan, an investigational therapy for patients with advanced small ...
FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma.
