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FDA Approves Immunoglobulin Therapeutic to Treat Primary Immunodeficiencies

June 18, 2024

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Global healthcare company, Grifols, announced on June 17, 2024 that its subsidiary Biotest has garnered its first FDA approval with the intravenous immunoglobulin (Ig) therapeutic, Yimmugo, which Grifols hopes to launch commercially in the United States in the second half of 2024 (1). FDA notified Biotest of the approval in a letter dated June 13, 2024 (2).

According to a press release from Grifols, Yimmugo was introduced in Europe at the end of 2022 and is being produced at a new, FDA-certified facility in Dreieich, Germany. This location was also previously approved for production and marketing throughout Europe.

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