Immune Globulin Articles
The U.S. Food and Drug Administration has approved ADMA Biologics’ supplemental biologics license application to expand the prescribing information to primary humoral immunodeficiency indication to pediatric patients 2 years of age and older.
U.S. Representatives Adrian Smith (R-NE-03) and Doris Matsui (D-CA-07) have introduced the PI Post Acute Access Act to expand access to lifesaving care for individuals with primary immunodeficiencies
Intravenous immune globulin (IVIG) improved clinical response rates in patients with autoimmune encephalitis (AE) who had inadequate response to steroid pulse therapy.
GC Biopharma has developed a proprietary enzyme-linked immunoassay (ELISA) that effectively mitigates heterophilic antibody interference to precisely measure factor XI (FXI) levels.
A recent study has found intravenous immune globulin (IVIG) therapy in infants with hemolytic disease of the fetus and newborn (HDFN) found that it could be beneficial.
According to a recent study, adding intravenous methylprednisolone to intravenous immune globulin induction therapy does not significantly increase remission rates among patients with chronic inflammatory demyelinating polyradiculoneuropathy.
GAMMAGARD LIQUID ERC (immune globulin infusion [human]) with less than or equal to 2 µg/mL IgA in a 10% solution, by prescription, is now available in the U.S.
The HyHub and HyHub Duo devices are now available in the U.S. for patients 17 years of age and older who are prescribed HYQVIA.
Grifols Therapeutics has initiated a voluntary withdrawal of four lots of Gamunex-C 10%.
A recent study showed treatment with intravenous immune globulin following infection from BCMA therapies yielded a 67 percent decrease in infections in patients with multiple myeloma.
The U.S. Food and Drug Administration has granted 510(k) clearance to Takeda’s HyHub and HyHub Duo for patients 17 years of age and older that allow HYQVIA [immune globulin infusion (human), 10% with recombinant human hyaluronidase] to be transferred from vials without using a needle in a home environment or clinical setting.
The U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for individuals 2 years of age and older with primary immunodeficiency (PI).