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

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

EYDENZELT
  • Active Ingredient(s): Aflibercept-boav
  • Strength: 2MG(0.05ML;40MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Celltrion Inc
  • Approval Date: 2 October 2025
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of patients with:
    • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
    • Macular Edema Following Retinal Vein Occlusion (RVO)
    • Diabetic Macular Edema (DME)
    • Diabetic Retinopathy (DR)
  • Approved Label:  2 October 2025 (PDF)
JASCAYD
  • Active Ingredient(s): Nerandomilast
  • Strength: 9MG; 18MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Boehringer Ingelheim
  • Approval Date: 7 October 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of idiopathic pulmonary fibrosis in adult patients.
  • Approved Label:  7 October 2025 (PDF)