Drug news
European Commission approves HyQvia for treatment of primary and secondary Immunodeficiencies
Baxter International Inc.and Halozyme Therapeutics, Inc. have announced that the European Commission has on 21 May 2013 granted Baxter marketing authorization in all European Union Member States for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies.
The FDA has issued a Complete Response Letter for HyQvia and requested additional preclinical data to support the biologics license application.
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