A consolidated list of all the FDA approved medications during the month of December 2025.

  • Nereus (tradipitant)  
    • For the prevention of vomiting induced by motion.
  • Yartemlea (narsoplimab-wuug)  
    • For hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and children aged two and older.
  • Aqvesme (mitapivat)  
    • For the treatment of anemia in adults with alpha- or beta-thalassemia.
  • Furoscix (furosemide) Expanded Indication
    • For the treatment of edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults and  pediatric patients weighing 43 kg or more.
  • Accrufer (ferric maltol) Expanded Indication
    • To treat pediatric patients ages 10 and older with iron deficiency.
  • Wegovy (semaglutide) New Formulation
    • New formulation as a once-daily pill for weight management and cardiovascular risk reduction in people with obesity or who are overweight.
  • Lunsumio Velo (mosunetuzumab) 
    • For the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
  • Oziltus (denosumab-mobz) Biosimilar to Xgeva
    • Multiple indications as a biosimilar to Xgeva - prevention of skeletal-related events in patients with multiple myeloma; treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity and in patients with bone metastases from solid tumors; treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
  • Boncresa (denosumab-mobz) Biosimilar to Prolia
    • Multiple indications as a biosimilar to Prolia - for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer and for the treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
  • Jascayd (nerandomilast) New Indication
    • For the treatment of progressive pulmonary fibrosis (PPF) in adults.
  • Myqorzo (aficamten) 
    • For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
  • Nufymco (ranibizumab-leyk) Biosimilar to Lucentis
    • Interchangeable biosimilar to Lucentis indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).
  • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)  
    • For patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
  • Fesilty (fibrinogen, human-chmt)  
    • For treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.
  • Exdensur (depemokimab-ulaa)  
    • As an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.
  • Addyi (flibanserin) Expanded Indication
    • For the treatment of Hypoactive Sexual Desire Disorder (HSDD) in women <65 years.
  • Enhertu (fam-trastuzumab - deruxtecan-nxki) New Indication
    • In combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.
  • Lerochol (lerodalcibep-liga)
    • For use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
  • Cardamyst (etripamil) New Indication
    • For the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
  • Akeega (niraparib and abiraterone acetate dual-action tablet) New Indication
    • For the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).
  • Daybue Stix (trofinetide) New Formulation
    • Powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older.
  • Orladeyo (berotralstat) Expanded Indication
    • For prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years.
  • Nuzolvence (zoliflodacin)  
    • For uncomplicated urogenital gonorrhea in adults and children 12 years and older who weigh at least 77 pounds.
  • Blujepa (gepotidacin) New Indication
    • For adult and paediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae. 
  • Uplizna (inebilizumab-cdon) New Indication
    • For the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive.
  • Waskyra (etuvetidigene autotemcel) 
    • For the treatment of Wiskott-Aldrich syndrome (WAS).
  • Flow FL-100 
    • For the treatment of moderate to severe major depressive disorder (MDD) in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication.
  • Omisirge (omidubicel-onlv) New Indication
    • For the treatment of Severe Aplastic Anemia (SAA).
  • Avance (acellular nerve allograft–arwx)  
    • For the treatment of adult and pediatric patients aged one month or older who suffer from sensory, mixed, or motor peripheral nerve discontinuities.
  • Breyanzi (lisocabtagene maraleucel) New Indication
    • For the treatment of adults with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy.
  • Jaypirca (pirtobrutinib) Expanded Indication
    • For the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor.
  • Armlupeg (pegfilgrastim-unne) Biosimilar to Neulasta
    • Multiple indications as a biosimilar to Neulasta: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; and to Increase survival in patients acutely exposed to myelosuppressive doses of radiation.

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