Approval update comes as a result of findings from Study 5310, which addressed Biktarvy’s pharmacokinetics, safety, and efficacy during pregnancy and postpartum periods in patients with HIV.
Beqvez, a one-time gene therapy, offers hope to patients with moderate to severe hemophilia B who use regular factor IX prophylaxis, suffer severe hemorrhages, or recurrent serious bleeding.
Companies reported that the new formulation of Coartem met required pharmacokinetic profiles and displayed promising efficacy and safety treating malaria in infants.