Biotest Achieves Milestone with FDA Approval for Yimmugo

Biotest AG has announced the approval of its intravenous immunoglobulin Yimmugo® by the U.S. Food and Drug Administration (FDA) for treating primary immunodeficiencies (PID). This approval allows Biotest to enter the U.S. market, potentially driving significant future sales and earnings growth.

The CEO of Biotest, Peter Janssen, highlighted the importance of this approval for global patient care. Yimmugo® is the first drug made at Biotest's new FDA-certified “Next Level” facility in Germany to achieve this U.S. approval. The facility and product met FDA requirements in the first approval cycle without delays.

Yimmugo® has already been approved for production and marketing in Europe and will now be available to American patients, promising to expand access to essential immunoglobulin therapies.