Brief: Xbrane Gets FDA BsUFA Review Date
04/06/2026 07:23
BRIEF-Xbrane Gets FDA BsUFA Review Date June 4 (Reuters) - Xbrane Biopharma AB XBRANE.ST:
SAID ON WEDNESDAY, U.S. FOOD AND DRUG ADMINISTRATION (FDA) ACCEPTED RESUBMITTED BIOLOGICS LICENSE APPLICATION FOR CO'S INVESTIGATIONAL BIOSIMILAR CANDIDATE TO LUCENTIS (RANIBIZUMAB)
FDA SET A BSUFA (BIOSIMILAR USER FEE ACT) ACTION DATE OF OCTOBER 29, 2026
CANDIDATE INTENDED TO BE MARKETED IN THE UNITED STATES UNDER THE BRAND NAME LUCAMZI
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