A consolidated list of all the FDA approved medications during the month of November 2025.
- Voyxact (sibeprenlimab-szsi)
- For the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
- Imfinzi (onasdurvalumab) New Indication
- For the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
- Itvisma (onasemnogene abeparvovec-brve)
- For the treatment of children two years and older, teens, and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene.
- Keytruda + Padcev (pembrolizumab with enfortumab vedotin-ejfv) New Indication
- As neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.
- Osvyrti (denosumab-desu) Biosimilar to Prolia
- For treatment of postmenopausal women with osteoporosis at high risk for fracture, 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, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
- Jubereq (denosumab-desu) Biosimilar to Xgeva
- For the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, 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 treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
- Koselugo (selumetinib) New Indication
- For the treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
- Eylea HD (aflibercept) New Indication
- For the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period.
- Hyrnuo (sevabertinib)
- For adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
- Epkinly (epcoritamab-bysp)
- For the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
- Redemplo (plozasiran)
- As an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
- Poherdy (pertuzumab-dpzb) Biosimilar to Perjeta
- Multiple indications for certain HER2-positive breast cancers, as a biosimilar to Perjeta.
- Komzifti (ziftomenib)
- For adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.
- Caplyta (lumateperone) New Indication
- As an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
- Darzalex Faspro (daratumumab and hyaluronidase-fihj) New Indication
- As a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM).
- Linzess (linaclotide) Expanded Indication
- For pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C).
- Kygevvi (doxecitine and doxribtimine)
- For the treatment of adults and pediatric patients living with thymidine kinase 2 deficiency (TK2d), with an age of symptom onset on or before 12 years.
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