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...
Cardinal Health recalls its Covidien and Cardinal Health brand urology and operating room-specific kits and trays that contain 0.9% sodium chloride ir...
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.
FDA publishes a draft guidance with an interim enforcement discretion policy for some Section 503 drug compounding using bulk drug substances.
FDA clears a Becton Dickinson 510(k) for what it describes as a novel blood collection device that gathers blood samples from a fingerstick that produ...
