FDA approves a fast-track designation for Invectys IVS-3001 antigen to combat renal cell cancer.
Lupin Pharmaceuticals recalls two lots of Tydemy oral contraceptive tablets due to out-of-specification test results at the 12-month stability time po...
FDA commissioner Robert Califf and DEA administrator Anne Milgram say they are taking multiple steps to ease a shortage of prescription stimulant drug...
FDA grants Actuate Therapeutics an orphan drug designation for elraglusib for treating patients with pancreatic cancer.
FDA warns Indias Intas Pharmaceuticals about CGMP and other violations at its drug manufacturing facility in Sanand, India.
FDA warns Alvin, TX-based Iso-Tex Diagnostics about CGMP violations in its production of finished drugs.
FDA warns Baxters Ahmedabad, India-based drug manufacturing facility about CGMP and other violations.
FDA clears a Teleflex 510(k) for expanded use for the QuikClot Control+ Hemostatic Device mild and moderate bleeding in cardiac surgical procedures a...
