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 in India, following an inspection last year.
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 in India, following an inspection last year.
FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for advanced melanoma.
FDA issues an early alert regarding a potential safety issue affecting certain sizing catheters manufactured by Cook Medical.
