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FDA & Government News

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April 04, 2025

First IgG4-RD Treatment Approved

A humanized monoclonal antibody that targets CD19+ B cells is first FDA-approved treatment for immunoglobulin G4–related disease, reducing flare risk and glucocorticoid use in clinical trials.

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April 02, 2025

FDA Approves Automated Latent TB Test

Revvity’s Auto-Pure 2400 platform for use with the T-SPOT.TB test to automate latent tuberculosis diagnostics was approved by the FDA.

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April 01, 2025

FDA Approves Freeze-Dried Jynneos Vaccine

Bavarian Nordic’s freeze-dried Jynneos vaccine offers logistical advantages over the liquid-frozen version, supporting long-term U.S. stockpiling and public health preparedness.

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