FDA Approves NUWIQ to Treat Hemophilia A

Photo of blood sample vials

The U.S. Food and Drug Administration ha approved Octapharma’s NUWIQ, antihemophilic factor (recombinant), an intravenous therapy for adults and children living with hemophilia A.

Gammaplex Approved for PI Patients 2 Years and Older

The U.S. Food and DrugAdministration (FDA) approved BioProducts Laboratory’s Gammaplex(immune globulin intravenous [human]5% liquid) for pediatric patients 2 years of age and older who have primary immunodeficiency disease (PI).

Recombinant IVIG Granted Orphan Drug Designation for CIDP

Pfizer (a licensee of Gliknik Inc.) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its recombinant intravenous immune globulin (IVIG)-mimetic drug
GL-2045 to treat chronic inflammatory demyelinating polyneuropathy (CIDP).