Original New Drug Application Approvals by US FDA 1-15 November 2025

31 Dec 2025
Original New Drug Application Approvals by US FDA 1-15 November 2025
New drug applications approved by US FDA as of 1-15 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.

KYGEVVI
  • Active Ingredient(s): Doxecitine; Doxribtimine
  • Strength: 2GM/PACKET;2GM/PACKET
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Ucb Inc
  • Approval Date: 3 November 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years.
  • Approved Label:  3 November 2025 (PDF)
KOMZIFTI
  • Active Ingredient(s): Ziftomenib
  • Strength: 200MG
  • Dosage Form(s) / Route(s): Capsule;oral
  • Company: Kura
  • Approval Date: 13 November 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.
  • Approved Label:  13 November 2025 (PDF)
POHERDY
  • Active Ingredient(s): Pertuzumab-dpzb
  • Strength: 420MG/14ML(30MG/ML)
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Shanghai Henlius Biotech
  • Approval Date: 13 November 2025
  • Submission Classification: NA
  • Indication(s): Indicated for:
    • Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
    • Use in combination with trastuzumab and chemotherapy as:
      • neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.
      • adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
    • Approved Label:  13 November 2025 (PDF)