Getinge recalls its CardioHelp Emergency Drive due to a possible blocking or impairment of its emergency crank.
Federal Register notice: FDA withdraws approval of Bayers Cipro (ciprofloxacin HCl) oral tablets under NDA #019537 and five related ANDAs that referen...
Federal Register notice: FDA sends to OMB an information collection revision entitled Time and Extent Applications (TEA) for Nonprescription Drug Prod...
The first two cell-based gene therapies for treating sickle cell disease in patients 12 years and older gain FDA approval Vertex Pharmaceuticals Casg...
Novartis reports updated Kisqali (ribociclib) data from the Phase 3 NATALEE trial that confirms an earlier benefit seen at an interim analysis.
FDA accepts for review an Alpha Cognition NDA for ALPHA-1062 for treating mild-to-moderate Alzheimers disease.
Regeneron says it will submit a BLA to FDA this year for its linvoseltamab multiple myeloma drug based on successful Phase 1/2 trial results.
Reps. Eshoo and McCaul introduce bipartisan legislation to strengthen pediatric drug development.
