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Home » Topics » Regulatory » Priority review

Priority review
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New chikungunya vaccine from Bavarian Nordic wins FDA nod

Feb. 18, 2025
By Lee Landenberger
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.
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US FDA approves Pivya for uncomplicated UTIs

April 24, 2024
By Lee Landenberger
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.
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Staphylococcus aureus

US FDA approves antibiotic Zevtera, Basilea seeks US partner

April 4, 2024
By Karen Carey
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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Stratagraft

Mallinckrodt wins FDA nod for regenerative skin therapy for burns

June 16, 2021
By Jennifer Boggs
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns.
Read More

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