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Fri, May 23, 2025

Priority review

Home » Topics » Regulatory » Priority review
  • Feb. 18, 2025
    By Lee Landenberger

    New chikungunya vaccine from Bavarian Nordic wins FDA nod

    With the U.S. FDA’s approval of Vimkunya, Bavarian Nordic A/S is now in the chikungunya virus infection mix along with Valneva SE’s Ixchiq. A single-dose, adjuvanted virus-like particle-based vaccine to protect against the chikungunya virus infection, Vimkunya is the first of its kind available in the U.S. for those age 12 and older.
  • April 24, 2024
    By Lee Landenberger

    US FDA approves Pivya for uncomplicated UTIs

    The U.S. FDA approved Utility Therapeutics Ltd.’s Pivya (pivmecillinam), an oral prodrug of injectable mecillinam, on its April 24 PDUFA date for female adults with uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
  • Staphylococcus aureus staph bacteria infection
    April 4, 2024
    By Karen Carey

    US FDA approves antibiotic Zevtera, Basilea seeks US partner

    In a long and winding regulatory road that began with two complete response letters 15 years ago, Allschwil, Switzerland-based Basilea Pharmaceutica Ltd. finally gained U.S. FDA approval of its intravenous cephalosporin antibiotic, Zevtera (ceftobiprole medocaril sodium), to treat Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia.
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