FDA tells isotretinoin manufacturers that they must modify their iPLEDGE Risk Evaluation and Mitigation Strategy to minimize the burden on patients, p...
FDA accepts an Ascendis Pharma NDA resubmission for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism.
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.
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...
