Original New Drug Application Approvals by US FDA (16-31 May 2026)

12 Jun 2026
Original New Drug Application Approvals by US FDA (16-31 May 2026)
New drug applications approved by US FDA as of 16-31 May 2026 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

HEPCLUDEX
  • Active Ingredient(s): Bulevirtide-gmod
  • Strength: 8.5MG
  • Dosage Form(s) / Route(s): Injection;powder,for Solution
  • Company: Gilead Sciences INC
  • Approval Date: 22 May 2026
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of chronic HDV infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on participants who achieved a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Approved Label:  22 May 2026 (PDF)
DECNUPAZ
  • Active Ingredient(s): Pivekimab Sunirine-pvzy
  • Strength: 2MG
  • Dosage Form(s) / Route(s): Vial;single-dose
  • Company: Abbvie INC
  • Approval Date: 27 May 2026
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
  • Approved Label:  27 May 2026 (PDF)
ZAYNICH
  • Active Ingredient(s): Zidebactam And Cefepime
  • Strength: 3G per Vial
  • Dosage Form(s) / Route(s): Injection;powder,for Solution
  • Company: Wockhardt Bio Ag
  • Approval Date: 29 May 2026
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms.
    Usage to Reduce Development of Drug-Resistant Bacteria
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZAYNICH and other antibacterial drugs, ZAYNICH should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Approved Label:  29 May 2026 (PDF)