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 January 8, 2026.

Upcoming FDA Decisions for the First Quarter of 2026
  • Tividenofusp alfa (BLA), January 5
    • Denali Therapeutics
    • For the treatment of Hunter syndrome.
  • Tabelecleucel (Resubmitted BLA), January 10
    • Atara Biotherapeutics
    • 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.
  • CUTX-101 (Resubmitted NDA), January 17
    • Johnson & Johnson
    • For the treatment of high-risk non-muscle invasive bladder cancer.
  • Enhertu (sBLA), January 23
    • AstraZeneca PLC
    • 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.
    • For the expanded use of Leniolisib as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome.
  • Clemidsogene Lanparvovec (RGX-121)(BLA), February 8
    • Regenxbio
    • For the treatment of Mucopolysaccharidosis II (MPS II).
  • Keytruda (sBLA), February 20
    • Merck & Co
    • Keytruda plus chemotherapy with or without bevacizumab for treatment of patients with platinum-resistant recurrent ovarian cancer.
  • Bysanti (NDA), February 21
    • Vanda Pharmaceuticals
    • For the acute treatment of bipolar I disorder and the treatment of schizophrenia.
  • ET-600 (NDA), February 25
    • Eton Pharmaceuticals
    • For the treatment of central diabetes insipidius, also known as arginine vasopressin deficiency.
  • Inqovi (sNDA), February 25
    • Otsuka Holdings
    • Inqovi plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy.
  • Dupixent (sBLA), February 28
    • Sanofi
    • For adults and children aged 6 years and older with allergic fungal rhinosinusitis.
  • Dupixent (sBLA), February 28
    • Regeneron Pharmaceutical
    • For adults and children aged 6 years and older with allergic fungal rhinosinusitis.
  • TransCon CNP (NDA), February 28
    • Ascendis Pharma
    • For the treatment of children with achondroplasia.
  • Palynziq (sBLA), February 28
    • Biomarin Pharmaceutical
    • For expand treatment to include adolescents aged 12-17 with phenylketonuria.
  • New Formulation of F18 (NDA), March 6
    • Lantheus Holdings
    • For a new formulation of F18 PSMA-targeted PET imaging agent to determine the presence or absence of recurrent and/or metastatic prostate cancer.
  • Sotyktu (sNDA), March 6
    • Bristol Myers Squibb
    • FDA decision on Sotyktu for the treatment of adults with active psoriatic arthritis.
  • Reproxalap (Resubmitted NDA), March 16
    • Aldeyra Therapeutics
    • FDA decision on Reproxalap for the treat of dry eye disease.
  • Imcivree (sNDA), March 20
    • Rhythm Pharmaceuticals
    • FDA decision on expanded use of Imcivree for the treatment of acquired hypothalamic obesity.
  • Linerixibat (NDA), March 24
    • GSK
    • For the treatment of cholestatic pruritus in patients with Primary Biliary Cholangitis.
  • Kresladi (Resubmitted BLA), March 28
    • Rocket Pharmaceuticals
    • For the treatment of severe Leukocyte Adhesion Deficiency-I.
  • LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit, March 29
    • Lantheus Holdings
    • For use with PET imaging for localization of somatostatin receptor-positive (SSTR+) neuroendocrine tumors in adult and pediatric patients.

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