Bavarian Nordic Announces FDA Acceptance and Priority Review of Biologics License Application for MVA-BN Smallpox Vaccine
BAVARIAN NORDIC R/I S/ADR (BVNRY)
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bavarian-nordic.com/investor.aspx
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Source: GlobeNewswire
COPENHAGEN, Denmark, December 21, 2018 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for the liquid-frozen version of the MVA-BN® for active immunization against smallpox in adults age 18 years and older. The FDA has granted priority review to the BLA, which means that the agency is targeting completion of the review in six months rather than the standard time of ten months. Priority review is granted by the FDA to applications for medicines that, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. If approved, MVA-BN would be the first and only approved non-replicating smallpox vaccine in the U.S. "The acceptance of our BLA is a significant milestone for Bavarian Nordic, and for our long-standing collaboration with the U.S. Government on the development of MVA-BN to ad
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- Morris & Dickson is the First U.S. Distributor for Bavarian Nordic's JYNNEOS®, the Only FDA-approved Mpox Vaccine [Yahoo! Finance]Yahoo! Finance
- Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the U.S. [Yahoo! Finance]Yahoo! Finance
- Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the U.S.GlobeNewswire
- Mpox cases in the US are on the rise as vaccination rates lag and new threats loom [CNN]CNN
- Mpox cases in the US are on the rise as vaccination rates lag and new threats loom [CNN]CNN