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 Chinas Shantou S.E.Z. Baojie Industry about CGMP violations in its production of finished drugs, some of which may be regulated as cosmetics...
Biotech executives, investors, and consultants say some companies are moving early clinical trials overseas due to fears of instability and slowness a...
FDA approves a Merck NDA for Welireg (belzutifan), an oral drug for treating adults and pediatric patients aged 12 and older with locally advanced, un...
FDA gives AbbVie accelerated approval for its Emrelis (telisotuzumab vedotin-tllv) for treating certain adult patients with locally advanced or metast...
