The Food and Drug Administration (FDA) provides the Prescription Drug User Fee Act date which marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee meeting is convened to assess drugs or devices under consideration. Presented below is a compiled list of drugs and devices, along with the anticipated decision date currently accurate as of October 15, 2025.

Upcoming FDA Decisions for Q4 2025

Tezspire (BLA), 10/19/2025

  • Amgen
  • Decision on Tezspire in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Epioxa (NDA), 10/20/2025

  • Glaukos
  • For the treatment of keratoconus.

Blenrep Combinations (BLA), 10/23/2025

  • GSK
  • Decision on Blenrep in combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for the treatment of multiple myeloma.

Revuforj (sNDA), 10/25/2025

  • Syndax Pharma
  • For the treatment of relapsed or refractory mutant NPM1 acute myeloid leukemia.

Winrevair (sBLA), 10/25/2025

  • Merck & Co
  • Decision to update the label of Winrevair to include the results of the Phase 3 ZENITH trial.

Elinzanetant (NDA), 10/26/2025

  • Bayer
  • For the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause.

Libtayo (sBLA), October 2025

  • Regeneron Pharmaceuticals
  • FDA decision on Libtayo as an adjuvant treatment for high-risk cutaneous squamous cell carcinoma.

Gazyva (sBLA), October 2025

  • Roche Holding
  • FDA decision on Gazyva for the treatment of lupus nephritis.

Plozasiran (NDA), 11/18/2025

  • Arrowhead Pharmaceuticals
  • For the treatment of familial chylomicronemia syndrome.

Sevabertinib (NDA), 11/28/2025

  • Bayer
  • For the treatment of patients with non-small cell lung cancer harboring HER2 activating mutations.

Ziftomenib (NDA), 11/30/2025

  • Kura Oncology
  • For the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a nucleophosmin 1 mutation. 

TransCon CNP (NDA), 11/30/2025

  • Ascendis Pharma
  • For the treatment of children with achondroplasia.

Breyanzi (sBLA), 12/05/2025

  • Bristol-Myers Squibb
  • For the expanded use as a potential treatment for adults patients with relapsed or refractory marginal zone lymphoma.

Avance Nerve Graft (BLA), 12/05/2025

  • AxoGen
  • For the surgical repair of severed peripheral nerves.

Pyrukynd (sNDA), 12/07/2025

  • Agios Pharmaceuticals
  • For the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.

Blujepa (Gepotidacin)(sNDA), 12/11/2025

  • GSK
  • For expanded use in treating uncomplicated urogenital gonorrhoea in patients 12 years of age and older.

ORLADEYO (berotralstat)(NDA), 12/12/2025

  • Biocryst Pharmaceuticals
  • As oral granules in pediatric patients with hereditary angioedema (HAE) aged 12 to 11 years. 

CARDAMYST (Resubmitted NDA), 12/13/2025

  • Milestone Pharmaceuticals
  • For the treatment of patients with paroxysmal supraventricular tachycardia.

Uplizna (sBLA), 12/14/2025

  • Amgen
  • For the treatment of patients with generalized myasthenia gravis (gMG).

Zoliflodacin (NDA), 12/15/2025

  • Innoviva
  • For the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older.

Depemokimab (BLA), 12/16/2025

  • GSK
  • As add-on maintenance treatment of asthma in adult and pediatric patients ages 12 years and older with Type 2 inflammation.

Depemokimab (BLA), 12/16/2025

  • GSK
  • For the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.

Setmelanotide (sNDA), 12/20/2025

  • Rhythm Pharmaceuticals
  • For the treatment of conditions associated with acquired hypothalamic obesity.

Narsoplimab (Resubmitted BLA), 12/26/2025

  • Omeros
  • For the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

Aficamten (NDA), 12/26/2025

  • Royalty Pharma
  • For the treatment of obstructive hypertrophic cardiomyopathy.

Aficamten (NDA), 12/26/2025

  • Cytokinetics
  • For the treatment of obstructive hypertrophic cardiomyopathy.

Tolebrutinib (NDA), 12/28/2025

  • Sanofi
  • For the treatment of non-relapsing secondary progressive multiple sclerosis.

Relacorilant (NDA)

  • Corcept Therapeutics
  • For the treatment of patients with endogenous hypercortisolism (Cushing’s syndrome).

Tridipitant (NDA), 12/30/2025

  • Vanda Pharmaceuticals
  • For the treatment of motion sickness.

IMFINZI (sBLA), Q4 2025

  • AstraZeneca
  • For the treatment of patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers.

ND0612 (Resubmitted NDA), Q4 2025

  • Mitsubishi Tanabe Pharma
  • FDA decision on ND0612 for the Treatment of Motor Fluctuations in people with Parkinson's Disease.

EYLEA HD Injection 8 mg (sBLA), Q4 2025

  • Regeneron Pharmaceuticals
  • FDA decision on EYLEA HD Injection 8 mg for both the treatment of macular edema following retinal vein occlusion and for broadening the dosing schedule to include every 4-week dosing across approved indications.

Denosumab Biosimilar to XGEVA (BLA), Q4 2025

  • Amneal Pharmaceuticals
  • FDA decision on Denosumab biosimilar to Prolia in the indication of osteoporosis.

Denosumab Biosimilar to XGEVA (BLA), Q4 2025

  • Amneal Pharmaceuticals
  • FDA decision on Denosumab biosimilar to Xgeva in the indication of bone cancer.

Troriluzole (NDA), Q4 2025

  • Biohaven
  • FDA decision on Troriluzole for the treatment of Spinocerebellar Ataxia.

Sign up for alerts and stay informed on the latest published guidelines and articles.

Copyright © 2025 Guideline Central, all rights reserved.