Emergent BioSolutions' Ixinity, a recombinant coagulation factor IX, has received FDA approval to manage bleeding episodes in hemophilia B patients. The agency based its approval on data from a global trial in which 84% of bleeding episodes were controlled by one or two infusions of the drug.
Baxter International has received the FDA's approval to market Rixubis, or coagulation factor IX (recombinant), for the treatment of children with hemophilia B. The drug was approved for use in routine prophylaxis, perioperative management and control of bleeding episodes.
Baxter International's Rixubis recombinant factor IX has been approved by the FDA for routine prophylactic treatment, perioperative management and the control and prevention of bleeding episodes in children with hemophilia B. The approval was based on a study involving 23 children younger than 12.
The FDA gave Perrigo its final approval on Tuesday to market the store-brand equivalent to Children's Zyrtec Allergy Syrup, an indoor/outdoor allergy drug for children aged 2 years and older. The company expects to start shipments of this generic version during the upcoming cough/cold/flu season.
People who perceived stress as a significant factor affecting their health had a twofold increased risk of suffering coronary heart disease compared with those who did not, a study in the European Heart Journal indicated.