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 accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma.
FDA cites significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient facility operated by Orchid Pharma Limited...
