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Bavarian Nordic receives special designation from FDA

The US Food and Drug Administration has awarded the so-called Breakthrough Therapy Designation to Bavarian Nordic’s vaccine candidate for RSV prevention in adults aged 60 years or older.

Photo: Philip Davali/Ekstra Bladet, Philip Davali

Danish Bavarian Nordic has received a particularly sought-after special regulatory status from the US Food and Drug Administration (FDA), the company announces in a press release.

Vaccine candidate MVA-BN RSV, which is designed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in patients 60 years or older, will now be processed by the FDA through an accelerated pathway.

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