FDA approves an Incyte supplemental BLA for Zynyz (retifanlimab-dlwr) in combination with carboplatin and paclitaxel for the first-line treatment of a...
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 ...
CBERs Nicole Verdun tells a Friends of Cancer Research meeting on next-generation therapies that FDA has evolved in the last decade in its ability to ...
FDA commissioner Marty Makary says the agency is planning to release in the coming days a vaccine development framework to help with predictability fo...
FDA warns Malaysias BioAsia Worldwide about CGMP violations in its production of finished drugs, some of which may be regulated as cosmetics.
