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FDA Approves Convenient Single-Vial Dosing for CSL Behring’s Zemaira for Patients with Alpha 1 Antitrypsin Deficiency

15:04 EDT 25 Apr 2019 | Speciality Pharma Journal

KING OF PRUSSIA, Pa., April 25, 2019 /PRNewswire/ — Global biotherapeutics leader CSL Behring today announced that the US Food and Drug Administration (FDA) has approved 4- and 5-gram vial sizes for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)], its therapy for treating Alpha 1 Antitrypsin Deficiency (Alpha 1).  This approval is significant for the Alpha 1 community …

Original Article: FDA Approves Convenient Single-Vial Dosing for CSL Behring’s Zemaira for Patients with Alpha 1 Antitrypsin Deficiency

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Biotherapeutics
The field encompassing therapeutic materials produced using biological means, including recombinant DNA technology. Biotherapeutics, also known as biotech drugs or biologics, are therapies derived from living organisms. By harnessing these living cells...