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BioWorld - Sunday, April 5, 2026

Priority review

Home » Topics » Regulatory » Priority review
  • Oral medication
    March 30, 2026
    By Nuala Moran

    AAD 2026: Targeted oral therapies challenge injected biologics

    Data presented at the 2026 American Academy of Dermatology (AAD) meeting have put the spotlight on the arrival of target-selective oral therapies that are set to challenge injected biologics in terms of efficacy, while offering greater convenience and improving access to treatment.
  • Empaveli 7 29
    July 29, 2025
    By Karen Carey

    Apellis’ Empaveli approved in US for two rare kidney diseases

    Following a priority review, Apellis Pharmaceuticals Inc. received U.S. FDA approval of a supplemental NDA making pegcetacoplan the second marketed treatment for complement 3 glomerulopathy and the first for primary immune complex membranoproliferative glomerulonephritis.
  • 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.
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Authors

  • Jennifer Boggs
  • Karen Carey
  • Lee Landenberger
  • Nuala Moran
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