A consolidated list of all the FDA approved medications during the month of September 2025.
- Rhapsido (remibrutinib)
- For adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.
- Qivigy (immune globulin intravenous, human-kthm)
- For treatment of adults with Primary humoral Immunodeficiency (PI).
- Xtrenbo (denosumab-qbde) Biosimilar to Xgeva
- Biosimilar to Xgeva, to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat 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 to treat hypercalcemia of malignancy refractory to biphosphonate therapymorbidity.
- Enoby (denosumab-qbde) Biosimilar to Prolia
- Biosimilar to Prolia, to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat 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.
- Clotic (clotrimazole otic solution)
- To treat fungal ear infections, specifically those caused by Aspergillus species and Candida species.
- Evkeeza (evinacumab-dgnb) Expanded Indication
- For the treatment of homozygous familial hypercholesterolemia (HoFH) in children aged between one and four.
- Bondlido (lidocaine topical system)
- For treating post-herpetic neuralgia in adults.
- Palsonify (paltusotine)
- For the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.
- Inluriyo (imlunestrant) New Indication
- For the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).
- Tremfya (guselkumab) New Formulation
- For subcutaneous induction in adults with ulcerative colitis.
- Forzinity (elamipretide hydrochloride)
- To improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kilograms (kg).
- Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) New Formulation
- For subcutaneous administration in adults across most solid tumor indications for Keytruda.
- Opzelura (ruxolitinib cream) Expanded Indication
- To treat mild-to-moderate atopic dermatitis in non-immunocompromised children aged two years and older.
- Aukelso (denosumab-kyqq) Biosimilar to Xgeva
- Biosimilar to Xgeva, to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat 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 to treat hypercalcemia of malignancy refractory to biphosphonate therapymorbidity.
- Bosaya (denosumab-kyqq) Biosimilar to Prolia
- Biosimilar to Prolia, to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat 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.
- Subvenite (lamotrigine) New Formulation
- For the treatment of epilepsy and bipolar disorder.
- Vyjuvek (beremagene geperpavec-svdt) Expanded Indication
- Expanded to include dystrophic epidermolysis bullosa (DEB) patients from birth.
- Enbumyst (bumetanide nasal spray)
- For the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults.
- Koselugo (selumetinib) Expanded Indication
- For pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
- Inlexzo (gemcitabine intravesical system)
- For adult patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
- Vonvendi (von Willebrand factor (recombinant)) Expanded Indication
- To include routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of bleeding in pediatric patients with VWD.
- Bilprevda (denosumab-nxxp) Biosimilar to Xgeva
- Biosimilar to Xgeva, for the prevention of skeletal related events in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
- Bildyos (denosumab-nxxp) Biosimilar to Prolia
- 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, for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at 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.
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