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Fri, May 23, 2025

PDUFA

Home » Topics » Regulatory » PDUFA
  • May 22, 2025
    By Mari Serebrov

    Split adcom vote not what Urogen envisioned

    More telling than the U.S. FDA’s Oncologic Drugs Advisory Committee’s 4-5 vote May 21 on the overall benefit-risk of Urogen Pharma Inc.’s UGN-102 (mitomycin) is that the panel’s urology specialists and the patient representative all voted yes, saying the drug would be an important alternative to what is often a continuing cycle of surgery for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
  • May 19, 2025
    By Mari Serebrov

    Street a bit uneasy ahead of Urogen adcom

    With a PDUFA date less than four weeks away, Urogen Pharma Inc. has been having a rough ride on the Street since the U.S. FDA released a joint briefing document for the May 21 Oncologic Drugs Advisory Committee meeting on UGN-102 (mitomycin).
  • April 29, 2025
    By Mari Serebrov

    PDUFA date miss another disappointing delay for Barth drug

    Stealth Biotherapeutics Inc., and, more importantly, patients with Barth syndrome, faced another disappointing delay April 29 when the U.S. FDA kicked its approval decision down the road for Stealth’s elamipretide.
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  • Mari Serebrov
  • Karen Carey
  • Randy Osborne
  • Lee Landenberger
  • Marian (YoonJee) Chu
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