The U.S. 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 November 25, 2025.

Upcoming FDA Decisions for December 2025

Breyanzi (sBLA), December 5

  • Bristol-Myers Squibb
  • To expand the use of Breyanzi as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma.

Avance Nerve Graft (BLA), December 5

  • AxoGen
  • For surgical repair of severed peripheral nerves.

Pyrukynd (sNDA), December 7

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

Blujepa (Gepotidacin)(sNDA), December 11

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

Orladeyo (berotralstat)(NDA), December 12

  • Biocryst Pharmaceuticals
  • For pediatric patients with hereditary angioedema (HAE) aged 2 to 11 years.

Cardamyst (Resubmitted NDA), December 13

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

Uplizna (sBLA), December 14

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

Zoliflodacin (NDA), December 15

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

Reproxalap (Resubmitted NDA), December 16

  • Aldeyra Therapeutics
  • For the treatment of dry eye disease.

Depemokimab (BLA), December 16

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

Depemokimab (BLA), December 16

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

Setmelanotide (sNDA), December 20

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

Narsoplimab (Resubmitted BLA), December 26

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

Aficamten (NDA), December 26

  • Cytokinetics
  • For the treatment of obstructive hypertrophic cardiomyopathy.

Aficamten (NDA), December 26

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

Tolebrutinib (NDA), December 28

  • Sanofi SA
  • To treat non-relapsing secondary progressive multiple sclerosis.

Tradipitant (NDA), December 30

  • Vanda Pharmaceuticals
  • For the treatment of motion sickness.

Relacorilant (NDA), December 30

  • Corcept Therapeutics
  • To treat patients with endogenous hypercortisolism (Cushing’s syndrome).

ONS-5010 (Resubmitted BLA), December 31

  • Outlook Therapeutics
  • For the treatment of wet age-related macular degeneration.

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