Ciplas InvaGen Pharmaceuticals unit recalls one lot of vigabatrin for oral solution, USP 500mg, due to seal integrity issues.
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...
