Original New Drug Application Approvals by US FDA (16-28 February 2026)

19 Mar 2026
Original New Drug Application Approvals by US FDA (16-28 February 2026)
New drug applications approved by US FDA as of 16-28 February 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.

BYSANTI
  • Active Ingredient(s): Milsaperidone
  • Strength: 1MG; 2MG; 4MG; 6MG; 8MG; 10MG; 12MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Vanda Pharms Inc
  • Approval Date: 20 February 2026
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for:
    • Treatment of schizophrenia in adults.
    • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
  • Approved Label:  20 February 2026 (PDF)
LOARGYS
  • Active Ingredient(s): Pegzilarginase-nbln
  • Strength: 0.1MG/KG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Immedica Pharma Ab
  • Approval Date: 23 February 2026
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction.
    This indication is approved under accelerated approval based on reduction of plasma arginine. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Approved Label:  23 February 2026 (PDF)
DESMODA
  • Active Ingredient(s): Desmopressin Acetate
  • Strength: 0.05MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Eton
  • Approval Date: 25 February 2026
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the management of central diabetes insipidus as antidiuretic replacement therapy for adults and pediatric patients.
      • Limitations of Use
    • DESMODA is not indicated for the treatment of nephrogenic diabetes insipidus.
  • Approved Label:  25 February 2026 (PDF)
YUVIWEL
  • Active Ingredient(s): Navepegritide
  • Strength: 1.3MG/VIAL; 2.8MG/VIAL; 5.5MG/VIAL
  • Dosage Form(s) / Route(s): Powder;subcutaneous
  • Company: Ascendis
  • Approval Date: 27 February 2026
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses.
    This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Approved Label:  27 February 2026 (PDF)