FDA approves Amneals Brekiya, the only dihydrogotamine mesylate autoinjector available to treat migraine and cluster headaches in adults.
FDA accepts a BioCryst NDA for Orladeyo to be used in pediatric patients with hereditary angioedema.
Merck's Keytruda meets a Phase 3 clinical trial primary endpoint of progression-free survival for treating patients with platinum-resistant recurrent ...
FDA says it is delaying for three months the PDUFA action date for Biohavens troriluzole to treat spinocerebellar ataxia.
IQVIA senior director David Cameron says FDA oncology initiatives like Project FrontRunner can help speed innovative cancer treatments to patients.
FDA approves Roches Ventana MET (SP44) RxDx Assay, a companion diagnostic to aid in determining MET protein expression in lung cancer patients to dete...
Nipro Renal Soultions recalls (Class 1) its MedicaLyte Liquid Bicarbonate Concentrate due to the potential for the presence of visible foreign matter ...
FDA warns Malaysias BioAsia Worldwide about CGMP violations in its production of finished drugs, some of which may be regulated as cosmetics.
