Last year saw more than 200 medications approved by the U.S. Food and Drug Administration (FDA). A total of 219 medications were approved by the FDA in 2025. The months that saw the most approvals were December (32), March (25), September (22), June (21), and October (20). Below, we have each month sorted, with each drug's generic form and indication provided.

The following is a consolidated list of all the FDA-approved medications from 2025.

January 2025
  • Symbravo (meloxicam and rizatriptan)
    • For the acute treatment of migraine with or without aura in adults.
  • Avtozma (tocilizumab-anoh) Biosimilar to Actemra
    • For the treatment of multiple diseases as a biosimilar to Actemra, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19).
  • Journavx (suzetrigine)
    • For the treatment of adults with moderate-to-severe acute pain.
  • Ozempic (semaglutide) New Indication
    • To reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD).
  • Enhertu (Daiichi (fam-trastuzumab - deruxtecan-nxki) Expanded Indication
    • For the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a Food and Drug Administration (FDA)-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
  • Leqembi (lecanemab-irmb) New Dosing
    • For the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.
  • Grafapex (treosulfan)
    • With fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients one year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
  • Spravato (esketamine) New Indication
    • For adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.
  • Datroway (datopotamab deruxtecan-dlnk)
    • For adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
  • Calquence (acalabrutinib) Expanded Indication
    • With bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).
  • Lumakras (sotorasib) Expanded Indication
    • For adults with metastatic colorectal cancer (mCRC) harboring a KRAS G12C mutation who have received certain chemotherapies.
  • Omvoh (mirikizumab-mrkz)
    • For the treatment of moderately to severely active Crohn's disease in adults.

February 2025

  • Odactra (House Dust Mite Allergen Tablet) Expanded Indication
    • For use in young children with house dust mite (HDM) allergy.
  • Sublocade (buprenorphine extended-release) New Dosing
    • Label update including a rapid initiation protocol and alternative injection sites, marking a significant advancement in the treatment of moderate to severe opioid use disorder (OUD).
  • Miudella (copper intrauterine system)
    • For the prevention of pregnancy in females of reproductive potential for up to three years.
  • BrainSense aDBS
    • For patients with Parkinson disease (PD).
  • Ctexli (chenodiol)
    • For the treatment of cerebrotendinous xanthomatosis (CTX) in adults.
  • Merilog (insulin-aspart-szjj) Biosimilar to NovoLog
    • For the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.
  • Xbryk (denosumab-dssb) 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.
  • Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) Expanded Indication
    • To protect against five meningococcal serogroups for individuals aged 10 to 25.
  • Vimkunya (chikungunya vaccine, recombinant)
    • For the prevention of disease caused by chikungunya virus in individuals 12 years of age and older.
  • Romvimza (vimseltinib)
    • To treat adult patients with symptomatic tenosynovial giant cell tumors (TGCT) who will not benefit from surgical resection.
  • Izervay (avacincaptad pegol intravitreal solution) Expanded Indication
    • For the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
  • Evrysdi (risdiplam) New Formulation
    • For the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
  • Adcetris (brentuximab vedotin) Expanded Indication
    • In combination with lenalidomide and rituximab, for adults with large B-cell lymphoma that recurs or fails to respond to at least two prior lines of therapy.
  • Gomekli (mirdametinib)
    • For the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
  • Emblaveo (aztreonam and avibactam)
    • In combination with metronidazole, for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens.
  • Susvimo (ranibizumab injection) New Indication
    • For the treatment of diabetic macular edema (DME).
  • Onapgo (apomorphine hydrochloride)
    • For the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD).
March 2025
  • Imfinzi (durvalumab) New Indication
    • With gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).
  • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Expanded Indication
    • For patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy.
  • Qfitlia (fitusiran)
    • For routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors.
  • Conexxence (denosumab-bnht) 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.
  • Bomyntra (denosumab-bnht) 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.
  • Vykat XR (diazoxide choline)
    • For the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS).
  • Cabometyx (cabozantinib) New Indication
    • For the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET); and 2) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET).
  • Egrifta WR (tesamorelin) New Formulation
    • New formulation for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
  • Blujepa (gepotidacin)
    • For treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older.
  • Amvuttra (vutrisiran) Expanded Indication
    • For the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits.
  • Tremfya (guselkumab) New Indication
    • For the treatment of adults with moderately to severely active Crohn's disease (CD).
  • Gozellix [gallium-68 (68Ga) gozetotide injection]
    • For PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
  • Fabhalta (iptacopan) New Indication
    • For the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria.
  • Arbli (losartan potassium) New Formulation
    • For the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes.
  • Gvoke VialDx (glucagon)
    • For use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.
  • Iluvien (fluocinolone acetonide intravitreal implant) Expanded Indication
    • For the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to diabetic macular edema (DME).
  • Soliris (eculizumab) Expanded Indication
    • For pediatric patients aged six years and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
  • Omlyclo (omalizumab-igec) Biosimilar to Xolair
    • Multiple indications as a biosimilar to Xolair, including: moderate to severe asthma in adults and children 6 years and older, chronic rhinosinusitis with nasal polyps, food allergy in patients 1 years of age and older, and chronic urticaria.
  • Furoscix (furosemide injection) Expanded Indication
    • To include treatment of edema in patients with chronic kidney disease (CKD).
  • Encelto (revakinagene taroretcel-lwey)
    • For the treatment of Macular Telangiectasia type 2 (MacTel).
  • Neffy (epinephrine nasal spray) Expanded Indication
    • For the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.).
  • Tevimbra (tocilizumab-jagr)
    • In combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).
  • Osenvelt (denosumab-bmwo) 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.
  • Stoboclo (denosumab-bmwo) 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.
  • TNKase (tenecteplase)
    • For treatment of acute ischemic stroke in adults.
April 2025
  • Vanrafia (atrasentan)
    • For the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.
  • Uplizna (inebilizumab-cdon) Expanded Indication
    • For adults living with Immunoglobulin G4-related disease (IgG4-RD).
  • Opdivo + Yervoy (ivolumab + ipilimumab) New Indication
    • in adult and pediatric patients age 12 or older with unresectable/metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).
  • Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) New Formulation
    • For the treatment of adult patients with generalized myasthenia gravis or gMG who are anti-acetylcholine receptor or AChR antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy or CIDP.
  • Jobevne (bevacizumab-nwgd) Biosimilar to Avastin
    • Multiple indications as a biosimilar to Avastin - treats multiple types of cancer.
  • Opdivo + Yervoy (nivolumab + ipilimumab) Expanded Indication
    • As a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
  • Livmarli (maralixibat)
    • For the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
  • Valtoco (diazepam nasal spray) Expanded Indication
    • For short-term treatment of seizure clusters that are different from a person's normal seizure pattern in people 2 years of age and older.
  • Isturisa (osilodrostat) New Indication
    • As second-line treatment of endogenous hypercortisolemia in adults with Cushing syndrome.
  • Dupixent (dupilumab) New Indication
    • To treat chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older.
  • Penpulimab-kcqx (penpulimab-kcqx) 
    • In combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).
  • Zevaskyn (prademagene zamikeracel)
    • Treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
  • Rinvoq (upadacitinib) New Indication
    • For the treatment of adults with giant cell arteritis (GCA).
  • Imaavy (nipocalimab-aahu)
    • For the treatment of generalized myasthenia gravis (gMG) in adults and adolescents 12 years of age and older.
May 2025
  • Yutrepia (treprostinil) 
    • For adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability.
  • Nucala (mepolizumab) New Indication
    • As an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.
  • Zoryve (roflumilast) New Formulation
    • For the treatment of plaque psoriasis in adults and adolescents 12 years and older.
  • Susvimo (ranibizumab injection) New Indication
    • For the treatment of diabetic retinopathy.
  • Jivi (antihemophilic factor (recombinant), PEGylated) Expanded Indication
    • For use in pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency).
  • Nuvaxovid (COVID-19 Vaccine, Adjuvanted) 
    • For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking).
  • Zynyz (retifanlimab-dlwr) 
    • In combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
  • Brekiya (dihydroergotamine mesylate) 
    • For the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.
  • Welireg (belzutifan) New Indication 
    • For the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL).
  • Emrelis (telisotuzumab vedotin-tllv)
    • For the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received prior systemic therapy.
  • Avmapki Fakzynja Co-pack (avutometinib + defactinib)
    • For the treatment of certain patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC).
  • HemiClor (chlorthalidone)
    • For the treatment of hypertension in adults, to lower blood pressure.
June 2025
  • Gamifant (emapalumab-lzsg) New Indication 
    • For the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
  • Vizamyl (flutemetamol F 18 injection) Expanded Indication
    • To include both quantification of amyloid burden for patients with suspected Alzheimer disease (AD) and use in therapy monitoring.
  • Benlysta (belimumab) New Formulation
    • New autoinjector for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy.
  • Datroway (datopotamab deruxtecan-dlnk) New Indication
    • For the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
  • Dupixent (dupilumab) New Indication
    • For the treatment of adult patients with bullous pemphigoid (BP).
  • Harliku (nitisinone)
    • For the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU).
  • Monjuvi (tafasitamab-cxix)  New Indication 
    • In combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
  • Yeztugo (lenacapavir)  
    • As pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg.
  • Andembry (garadacimab-gxii)  
    • For prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
  • Keytruda (pembrolizumab)  New Indication
    • For the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
  • mRESVIA (respiratory syncytial virus vaccine)  Expanded Indication
    • For adults aged 18-59 who are at an increased risk of contracting severe RSV disease.
  • Zusduri (mitomycin)  
    • For adults with Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC).
  • Brukinsa (zanubrutinib) New Formulation
    • A new tablet formulation for all five approved lymphoma indications.
  • Mavyret (glecaprevir/pibrentasvir) Expanded Indication
    • For the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.
  • Ibtrozi (taletrectinib)
    • For ROS1-positive locally advanced or metastatic non–small cell lung cancer (NSCLC).
  • Xifyrm (meloxicam injection)
    • For the management of moderate-to-severe pain in adults.
  • Widaplik (telmisartan, amlodipine and indapamide)
    • For the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure.
  • Enflonsia (clesrovimab-cfor)
    • For the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season.
  • Sonu Band Expanded Indication
    • For at-home treatment of moderate-to-severe nasal congestion in pediatric patients aged 12 and up.
  • Nubeqa (darolutamide) New Indication
    • For the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC).
  • Xenoview (xenon Xe 129 hyperpolarized) Expanded Indication
    • For use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older.
July 2025
  • Empaveli (pegcetacoplan) New Indication
    • For the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
  • Sephience (sepiapterin)
    • For the treatment of children and adults living with phenylketonuria (PKU).
  • Skytrofa (lonapegsomatropin-tcgd) New Indication
    • For the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production.
  • Doptelet / Doptelet Sprinkle (avatrombopag) Expanded Indication
    • For the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a prior therapy - also includes a new sprinkle formulation for children under six years old.
  • Anzupgo (delgocitinib)
    • For adults with moderate to severe chronic hand eczema (CHE) who have not responded adequately to prior topical corticosteroids or for whom corticosteroid use is not advisable.
  • Shingrix (zoster vaccine recombinant, adjuvanted) New Formulation
    • A new prefilled syringe presentation, for the prevention of herpes zoster.
  • Kirsty (insulin aspart-xjhz) Biosimilar to NovoLog
    • Biosimilar to and interchangeable with Novolog, to improve glycemic control in adults and pediatric patients with diabetes mellitus.
  • Kerendia (finerenone)  
    • To treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%.
  • SIR-Spheres Y-90 (Yttrium-90 microspheres) Expanded Indication
    • For the treatment of patients with unresectable hepatocellular carcinoma (HCC).
  • Ekterly (sebetralstat)
    • For the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
  • Lynozyfic (linvoseltamab-gcpt)
    • To treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody.
  • Zegfrovy (sunvozertinib)
    • For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
August 2025
  • Modeyso (dordaviprone)
    • For the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy
  • Ajovy (fremanezumab-vfrm)
    • For the preventive treatment of episodic migraine in children and adolescents aged 6-17 who weigh 45 kilograms or more
  • Hernexeos (zongertinib)
    • For the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy
  • KETARx (ketamine)
    • For the treatment of post-surgical pain
  • Brinsupri (brensocatib)
    • To treat non-cystic fibrosis bronchiectasis (NCFBE) in adults and kids ages 12 and older
  • Papzimeos (zopapogene imadenovec-drba)
    • For the treatment of adults with recurrent respiratory papillomatosis (RRP)
  • Wegovy (semaglutide)
    • For the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis but without cirrhosis
  • Tonmya (cyclobenzaprine hyrdochloride)
    • For the treatment of fibromyalgia in adults
  • Dawnzera (donidalorsen)
    • For prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older
  • Repatha (evolcumab)
    • To include patients at an increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C)
  • Comirnaty (LP.8.1; COVID-19 vaccine, mRNA)
    • For use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19
  • Spikevax/mNexspike (LP.8.1; COVID-19 vaccine, mRNA)
    • For individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older
  • Nuvaxovid (COVID-19 vaccine, adjuvanted)
    • For the prevention of COVID-19 in adults 65 years and older or individuals 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19
  • Wayrilz (rilzabrutinib)
    • For adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment
  • Leqembi Iqlik (lecanemab-irmb)
    • For once weekly subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's Disease
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.
October 2025
  • Omvoh (mirikizumab-mrkz)
    • For subcutaneous use in adults with moderately to severely active ulcerative colitis (UC).
  • Winrevair (sotatercept-csrk) Expanded Indication
    • For the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death.
  • Javadin (clonidine hydrochloride)  
    • For the treatment of hypertension in adult patients to lower blood pressure.
  • Revuforj (revumenib) New Indication
    • For the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options.
  • Lynkuet (elinzanetant)  
    • For the treatment of moderate to severe hot flashes due to menopause.
  • Blenrep (belantamab mafodotin-blmf)  
    • In combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.
  • Contempo (fosfomycin)  
    • For the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae.
  • Epioxa (riboflavin 5’-phosphate ophthalmic solution)  
    • For use in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older.
  • Ferabright (ferumoxytol injection)  
    • For magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.
  • Yuflyma (adalimumab-aaty) Expanded Indication 
    • To include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older.
  • Gazyva (obinutuzumab) New Indication 
    • For the treatment of adults with active lupus nephritis in combination with standard of care.
  • Tezspire (tezepelumab-ekko) New Indication 
    • For the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.
  • Rybelsus (semaglutide) New Indication 
    • To reduce the risk of major adverse cardiovascular events (MACE) such as CV death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events.
  • Rinvoq (upadacitinib) Expanded Indication 
    • For the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD).
  • Uzedy (risperidone) Expanded Indication 
    • As a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder (BD-I) in adults.
  • Eydenzelt (aflibercept-boav) Biosimilar to Eylea
    • For the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).
  • Libtayo (cemiplimab-rwlc) New Indication
    • For the adjuvant, or postsurgical, treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
  • Lasix ONYU (furosemide injection) New Indication
    • For the treatment of edema (due to fluid overload) in adult patients with chronic heart failure.
  • Simponi (golimumab) New Indication
    • To treat children with moderately to severely active ulcerative colitis (UC) weighing at least 15 kg.
  • Jascayd (nerandomilast)  
    • To treat idiopathic pulmonary fibrosis (IPF).
  • Zoryve (roflumilast)  Expanded Indication
    • For treating mild-to-moderate atopic dermatitis in children aged 2-5 years.
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.
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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