Original New Drug Application Approvals by US FDA (16-30 November 2025)

05 Jan 2026
Original New Drug Application Approvals by US FDA (16-30 November 2025)
New drug applications approved by US FDA as of 16-30 November 2025 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.

REDEMPLO
  • Active Ingredient(s): Plozasiran Sodium
  • Strength: EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)
  • Dosage Form(s) / Route(s): Solution;subcutaneous
  • Company: Arrowhead
  • Approval Date: 18 November 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
  • Approved Label:  18 November 2025 (PDF)
HYRNUO
  • Active Ingredient(s): Sevabertinib
  • Strength: 10MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Bayer Healthcare
  • Approval Date: 19 November 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

    This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Approved Label:  19 November 2025 (PDF)
VOYXACT
  • Active Ingredient(s): Sibeprenlimab-szsi
  • Strength: 400MG/2ML(200MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Otsuka Pharm Co Ltd
  • Approval Date: 25 November 2025
  • Submission Classification: NA
  • Indication(s): Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
    This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
  • Approved Label:  25 November 2025 (PDF)