People for the Ethical Treatment of Animals urges FDA to move away from animal experiments in its labs and use more non-animal, human-relevant researc...
FDA accepts for review a Pfizer BLA for its anti-tissue factor pathway inhibitor candidate marstacimab for treating hemophilia A or hemophilia B.
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 issues a guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.
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...
