HOBOKEN, N.J.--(BUSINESS WIRE)--Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved Octagam 10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid ...

Immune Globulin Intravenous (Octagam (5 gm)) is a blood product administered intravenously, prescribed for primary immunodeficiency. GIV boosts the body's natural response in patients with compromised ...

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The approval was based on data from the ProDERM study, which evaluated the efficacy and safety of Octagam 10% in 95 adults with dermatomyositis. The Food and Drug Administration (FDA) has approved ...

LACHEN, Switzerland (Oct. 6, 2022) – Octapharma announced today the results from the ProDERM study on the efficacy and safety of Octagam ® 10% [Immune Globulin Intravenous (Human)], in adult ...

The FDA approved intravenous immunoglobulins (IVIG; Octagam 10%) for treating adults with dermatomyositis, a rare chronic autoimmune disease, drugmaker Octapharma announced on Tuesday. Support for the ...

The Company has decided in conjunction with the FDA to suspend further administration of Octagam 10% from these specific production lots. Octapharma has initiated a voluntary market withdrawal of ...

PARAMUS, N.J.--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Octapharma USA for a phase three clinical trial on ...

FDA Approval Based on Positive Results of International, Multi-center ProDERM Study PARAMUS, N.J., July 20, 2021--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has granted approval to ...

The first trial of this IVIG preparation in Alzheimer's evaluated six different doses of Octagam 10 percent against two placebo comparators in a six-month trial of 58 people with mild to moderate AD.

PARAMUS, N.J. (May 20, 2020) - The U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Octapharma USA for a phase three clinical trial on ...

ProDERM Study Results of octagam® 10% Treatment in Patients With Dermatomyositis Published in the New England Journal of Medicine Back to video LACHEN, Switzerland — Octapharma announced today the ...