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 December 21, 2025.

Upcoming FDA Decisions for January 2026

Tividenofusp alfa (BLA), January 5

  • Denali Therapeutics
  • For the treatment of Hunter syndrome.

Tabelecleucel (resubmitted BLA), January 10

  • Atara Biotherapeutics
  • As monotherapy for the treatment of Epstein-Barr virus positive post-transplant Lymphoproliferative disease.

FILSPARI (sNDA), January 13

  • Travere Therapeutics
  • For the treatment of focal segmental glomerulosclerosis (FSGS).

FILSPARI (sNDA), January 13

  • Ligand Pharmaceuticals
  • For the treatment of focal segmental glomerulosclerosis (FSGS).

Cerezyme (sBLA), January 13

  • Sanofi
  • To treat patients with Gaucher disease type 3 (GD3), with no age limitation for patients with GD1 and GD3.

TAR-200 (NDA), January 17

  • Johnson & Johnson 
  • For the treatment of high-risk non-muscle invasive bladder cancer.

ENHERTU (sBLA), January 23

  • AstraZeneca
  • In combination with Pertuzumab for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

Anaphylm (NDA), January 31

  • Aquestive Therapeutics
  • For the treatment of Type 1 allergic reactions, including anaphylaxis.

Leniolisib (sNDA), January 31

  • Pharming Group N.V.
  • The expanded use of Leniolisib as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome.

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