FDA approves an Abon Pharmaceuticals ANDA for clofarabine injection, 20 mg/20 mL, single-use vial, a generic copy of Genzymes Clolar injection.
Abbott recalls specific lots of three catheters NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PT...
FDAs New England District Office warns Oxford Performance Materials about Quality System violations in its manufacturing of 3D-printed cranial and max...
FDAs Seattle District Office warns Vidco, Inc., about Quality System and Medical Device Reporting Regulation violations in its manufacturing of patien...
FDAs New Jersey District Office warns Vertical Pharmaceuticals about Postmarketing Adverse Drug Experience reporting violations.
FDA grants Sangamo Therapeutics a fast track designation for SB-525, a clinical stage complementary-DNA gene therapy candidate for hemophilia A.
FDA releases its latest batch of Warning Letters that includes Howard Phillips LLC., International Medsurg Connection, Oxford Performance Materials, V...
FDA approves a Pharmadax ANDA for a generic copy of Seroquel XR (quetiapine fumarate) extended release tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 ...