LYNOZYFIClinvoseltamab-gcpt7/2/2025To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibodyLynozyfic BRINSUPRIbrensocatib8/12/2025To treat non-cystic fibrosis bronchiectasisBrinsupri [ZEGFROVY](https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials…
LYNOZYFIClinvoseltamab-gcpt7/2/2025To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibodyLynozyfic BRINSUPRIbrensocatib8/12/2025To treat non-cystic fibrosis bronchiectasisBrinsupri ZEGFROVYsunvozertinib7/2/2025For use as a single agent for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutationsZegfrovy MODEYSOdordaviprone08/06/2025To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapModeyso SEPHIENCEsepiapterin07/28/2025To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted dietSephience ANZUPGOdelgocitinib07/23/2025To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate responseAnzupgo EKTERLYsebetralstat7/3/2025To treat acute attacks of hereditary angioedemaEkterly ANDEMBRYgaradacimab6/17/2025To prevent attacks of hereditary angioedemaAndemry IBTROZItaletrectinib6/11/2025To treat locally advanced or metastatic ROS1-positive non-small cell lung cancerIbtrozi ENFLONSIAclesrovimab6/9/2025To treat respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infantsEnflonsia EMRELIStelisotuzumab vedotin-tllv5/14/2025To treat adult patients with locally advanced or metastatic non-squamous non-small cell lung cancerEmrelis TRYPTYRacoltremon5/28/2025To treat the signs and symptoms of dry eye diseaseTryptyr IMAAVYnipocalimab-aahu4/29/2025To treat generalized myasthenia gravisImaavy AVMAPKI FAKZYNJA CO-PACKavutometinib; defactinib4/28/2025To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapyAvmapki Fakzynja Co-Pack PENPULIMAB-KCQXpenpulimab-kcqx4/23/2025To treat adult patients with metastatic or recurrent, locally advanced non-keratinizing nasopharyngeal cancerpenpulimab-kcqx VANRAFIAatrasentan4/2/2025To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progressionVanrafia QFITLIAfitusiran3/28/2025To prevent or reduce the frequency of bleeding episodes in hemophilia A or BQfitlia BLUJEPAgepotidacin3/25/2025For the treatment of female adult and pediatric patients 12 years of age and olderBlujepa ROMVIMZAvimseltinib2/17/2025To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidityRomvimza GOMEKLImirdametinib2/11/2025For treatment in adults and children 2 years of age and older with neurofibromatosis type 1 (NF1)Gomekli JOURNAVXsuzetrigine1/30/2025For the treatment of moderate to severe acute pain in adultsJournavx GRAFAPEXtreosulfan1/21/2025For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patientsGrafapex ALYFTREKvanzacaftor/tezacaftor/deutivacaftor12/20/2024For the treatment of cystic fibrosis (CF) in patients 6 years of age and olderAlyftrek ALHEMOconcizumab12/20/2024For routine prophylaxis to prevent bleeding episodes in hemophilia A and BAlhemo IOMERVUiomeprol11/27/2024Is used during an arteriogram to visualize blood vessels in adult and pediatric patientsIomervu RAPIBLYKlandiolol hydrochloride11/22/2024For short-term reduction of ventricular rate in adults with supraventricular tachycardia.Rapiblyk TRYNGOLZAolezarsen12/19/2024To treat familial chylomicronemia syndromeTryngolza COBENFYxanomeline tartrate and trospium chloride9/26/2024To treat schizophreniaCobenfy ATTRUBYacoramidis11/22/2024To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosisAttruby ITOVEBIinavolisib10/10/2024To treat locally advanced or metastatic breast cancerItovebi HYMPAVZImarstacimab10/11/2024To prevent or reduce bleeding episodes related to hemophilia A or BHympavzi LAZCLUZElazertinib8/19/2024To treat non-small cell lung cancerLazcluze MIPLYFFAarimoclomol9/20/2024To treat Niemann-Pick disease type CMiplyffa AQNEURSAlevacetylleucine9/24/2024Treatment of Niemann-Pick disease type CAqneursa NIKTIMVOaxatilimab-csfr8/14/2024To treat chronic graft-versus-host disease (cGVHD)Niktimvo EBGLYSSlebrikizumab-lbkz9/13/2024An interleukin-13 antagonist indicated for the treatment of adult and pediatric patients 12 years of age and olderEbglyss LUMISIGHTpegulicianine4/17/2024To use as an optical imaging agent for the detection of cancerous tissueLumisight MIEBOperfluorohexyloctane ophthalmic solution5/18/2023Treatment for patients with the signs and symptoms of dry eye disease (DED)Miebo AGAMREEvamorolone10/26/2023Treatment of Duchenne muscular dystrophyAgamree AMVUTTRAvutrisiran6/13/2022To treat polyneuropathy of hereditary transthyretin-mediated amyloidosisAmvuttra ANKTIVAnogapendekin alfa inbakicept-pmnl4/22/2024To treat a subtype of non-muscle invasive bladder cancer (NMIBC), called carcinoma in situ (CIS)Anktivia APHEXDAmotixafortide9/8/2023To mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myelomaAphexda AUGTYROrepotrectinib11/15/2023To treat ROS1-positive non-small cell lung cancerAugtyro BEYFORTUSnirsevimab7/17/2023Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease.Beyfortus BIMZELXbimekizumab-bkzx10/17/2023Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.Bimzelx BIZENGRIzenocutuzumab-zbco12/4/2024To treat non-small cell lung cancer and pancreatic adenocarcinomaBizengri BRENZAVVY bexagliflozin1/20/2023To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exerciseBrenzavvy BRIUMVIublituximab-xiiy12/28/2022To treat relapsing forms of multiple sclerosisBriumvi CAMZYOSmavacamten4/28/2022To treat certain classes of obstructive hypertrophic cardiomyopathyCamzyos CIBINQOabrocitinib1/14/2022Treatment of adults with refractory, moderate-to-severe atopic dermatitisCibinqo COLUMVIglofitamab-gxbm6/15/2023Treatment of diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapyColumvi CRENESSITYcrinecerfont12/13/2024To treat classic congenital adrenal hyperplasia Crenessity DATROWAYdatopotamab deruxtecan-dlnk1/17/2025To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic diseaseDatroway DAXXIFYdaxibotulinumtoxin A9/7/2022To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity.Daxxify DAYBUEtrofinetide3/12/2023To treat Rett syndrome.Daybue DEFENCATHtaurolidine, heparin11/15/2023To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter.Defencath DUVYZATgivinostat3/21/2024Treatment of Duchenne muscular dystrophy in individuals aged 6 years and olderDuvyzat ELAHEREmirvetuximab soravtansine-gynx11/14/2022To treat patients with recurrent ovarian cancer that is resistant to platinum therapyElahere ELFABRIOpegunigalsidase alfa-iwx5/9/2023An enzyme replacement therapy that is used for the treatment of Fabry disease in adult patients.Elfabrio ELREXFIOelranatamab-bcmm8/14/2023To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapyElrexfio ELUCIREMgadopiclenol9/21/2022To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the bodyElucirem ENJAYMOsutimlimab-jome2/4/2022To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin diseaseEnjaymo ENSACOVEensartinib12/18/2024To treat non-small cell lung cancerEnsacove EPKINLYepcoritamab-bysp5/19/2023To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapyEpkinly EXBLIFEPcefepime and enmetazobactam2/22/2024For the treatment of patients 18 years and older with complicated urinary tract infections (cUTI)Exblifep EXXUAgepirone9/22/2023Treatment of major depressive disorderExxua FABHLATAiptacopan12/5/2023Treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)Fabhlata FILSPARIsparsentan2/17/2023To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progressionFilspari FILSUVEZbirch triterpenes12/18/2023To treat wounds associated with dystrophic and junctional epidermolysis bullosaFilsuvez FLYRCADOflurpiridaz F 18 Injection9/27/2024A radioactive diagnostic drug to evaluate for myocardial ischemia and infarctionFlyrcado FRUZAQLAfruquintinib11/8/2023To treat refractory, metastatic colorectal cancerFruzaqla IMJUDOtremelimimab-actl10/21/2022To treat unresectable hepatocellular carcinomaImjudo INPEFAsotagliflozin5/26/2023Treatment of heart failureInpefa IQIRVOelafibranor6/10/2024To treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCAiqirvo IZERVAYavacincaptad pegol intravitreal solution8/4/2023To treat geographic atrophy secondary to age-related macular degenerationIzervay JAYPIRCApirtobrutinib1/27/2023To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitorJaypirca JOENJAleniolisib3/24/2023Treatment of activated phosphoinositide 3-kinase delta syndrome.Joenja JESDUVROQdaprodustat2/1/2023Treatment of anemia caused by chronic kidney disease for adults on dialysis for at least four months.Jesduvroq KIMMTRAKtebentafusp1/25/2022To treat unresectable or metastatic uveal melanomaKimmtrak KISUNLAdonanemab-azbt7/2/2024To treat people with Alzheimer’s diseaseKisunla KRAZATIadagrasib12/12/2022Prescription medicine used to treat adult patients with non-small cell lung cancerKrazati LAMZEDEvelmanase alfa-tycv2/16/2023To treat non-central nervous system manifestations of alpha-mannosidosisLamzede LEQEMBIlecanemab-irmb1/6/2023Treatment of Alzheimer’s diseaseLeqembi LEQSELVIdeuruxolitinib7/25/2024Indicated for the treatment of adults with severe alopecia areata (AA).Leqselvi LETYBOletibotulinumtoxinA2/29/2024To temporarily improve the appearance of moderate-to-severe glabellar linesLetybo LIVDELZIseladelpar8/14/2024To treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.Livdelzi LUNSUMIOmosunetuzumab-axgb12/22/2022To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphomaLunsumio LYTGOBIfutibatinib9/30/2022To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangementsLytgobi MOUNJAROtirzepatide5/13/2022To improve blood sugar control in diabetes, in addition to diet and exerciseMounjaro NEMLUVIOnemolizumab-ilto8/12/2024To treat prurigo nodularisNemluvio NEXOBRIDanacaulase-bcdb12/28/2022To remove charred tissue in adults with deep second degree and/or third degree burns from heat sourcesNexobrid NGENLAsomatrogon-ghla6/27/2023Treatment of growth failure due to inadequate secretion of endogenous growth hormoneNgenla OGSIVEOnirogacestat11/27/2023To treat adults with progressing desmoid tumors who require systemic treatmentOgsiveo OHTUVAYREensifentrine6/26/2024For the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.Ohtuvayre OJEMDAtovorafenib4/23/2024To treat certain types of brain tumors (cancers) called gliomas in patients 6 months and olderOjemda OJJAARAmomelotinib9/15/2023to treat a rare type of bone marrow disorder called myelofibrosis (MF) in adults with anemiaOjjaara OMLONTIoomidenepag isopropyl9/22/2022Reduces elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertensionOmlonti OPDUALAGnivolumab and relatlimab-rmbw3/18/2022Treatment of adults and pediatric patients 12 years of age or older with a type of skin cancer called melanoma that cannot be removed by surgery (unresectable) or has spread to other parts of the body (metastatic).Opdualag ORLYNVAHsulopenem etzadroxil and probenecid10/25/2024Treatment of uncomplicated urinary tract infections (uUTI)Orlynvah ORSERDUelacestrant1/27/2023To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.Orserdu PAXLOVIDnirmatrelvir, ritonavir5/25/2023To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19Paxlovid PIASKYcrovalimab-akkz6/20/2024Treatment of paroxysmal nocturnal hemoglobinuriaPiasky PLUVICTOlutetium Lu 177 vipivotide tetraxetan3/23/2022To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapiesPluvicto POMBILITIcipaglucosidase alfa-atga9/28/2023the treatment of adult patients with late-onset Pompe disease (LOPD)Pombiliti Opfolda POSLUMAflotufolastat F 185/25/2023To detect specific cancer lesions in males with prostate cancerPosluma PYRUKYNDmitapivat2/17/2022Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiencyPyrukynd QALSODYtofersen4/25/2023Treatment of amyotrophic lateral sclerosis in adults who have a SOD1 gene mutationQalsody QUVIVIQdaridorexant1/7/2022Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.Quvivq RELYVRIOsodium phenylbutyrate and taurursodiol9/29/2022To treat amyotrophic lateral sclerosis (ALS)Relyvrio REVUFORJ revumenib11/15/2024To treat relapsed or refractory acute leukemiaRevuforj REZDIFFRAresmetirom3/14/2024To treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.Rezdiffra REZLIDHIAolutasidenib12/1/2022Treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutationRezlidhia ZAYOrezafungin for injection3/22/2023To treat candidemia and invasive candidiasisRezzayo RIVFLOZAnedosiran9/29/2023To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney functionRivfloza ROLVEDONeflapegrastim9/9/2022To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropeniaRolvedon RYSTIGGOrozanolixizumab-noli6/26/2023To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positiveRystiggo RYTELOimetelsta6/6/2024to treat a condition called low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with anemiaRytelo RYZNEUTAefbemalenograstim alfa-vuxw11/11/2023To treat neutropeniaRyzneuta SKYCLARYSomaveloxolone2/28/2023To treat Friedrich’s ataxiaSkyclarys SOFDRAsofpironium bromide6/18/2024An anticholinergic antiperspirant approved for primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.Sofdra SOHONOSpalovarotene8/16/2023To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressivaSohonos SOTYKTUdeucravacitinib9/9/2022To treat moderate-to-severe plaque psoriasisSotyktu SPEVIGOspesolimab-sbzo9/1/2022To treat generalized pustular psoriasis flaresSpevigo SUNLENCAlenacapavir12/22/2022To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerationsSunlenca TALVEYtalquetamab-tgvs8/10/2023To treat a form of blood cancer called multiple myelomaTalvey TECVAYLI teclistamab-cqyv10/25/2022To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapyTecvayli TERLIVAZterlipressin9/14/2022Treatment to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney functionTerlivaz TEVIMBRAtislelizumab-jsgr3/14/2024To treat unresectable or metastatic esophageal squamous cell carcinomaTevimbra TRUQAPcapivasertib11/16/2023To treat breast cancer that meets certain disease criteriaTruqap TZIELDteplizumab-mzwv11/17/2022Used to delay the onset of type 1 diabetes in children and adults who are at high risk for type 1 diabetesTzield UNLOXCYTcosibelimab-ipdl12/13/2024To treat cutaneous squamous cell carcinomaUnloxcyt VABYSMOfaricimab-svoa1/28/2022To treat neovascular (wet) aged-related macular degeneration and diabetic macular edemaVabysmo VAFSEOvadadustat3/27/2024To treat anemia due to chronic kidney diseaseVafseo VANFLYTAquizartinib7/20/2023To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteriaVanflyta VELSIPITYetrasimod10/12/2023To treat moderately to severely active ulcerative colitis in adultsVelsipity VEOPOZpozelimab-bbfg8/18/2023To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE diseaseVeopoz VEOZAHfezolinetant5/12/2023To treat moderate to severe hot flashes caused by menopauseVeozah VIVJOAoteseconazole4/26/2022To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potentialVivjoa VONJOpacritinib2/28/2022To treat adult patients with a rare type of bone marrow disorder called myelofibrosis with platelet counts below 50,000/µL.Vonjo VOQUEZNAvonoprazan fumarate, amoxicillin5/3/2022Treatment of Helicobacter pylori infectionVoquezna VORANIGOvorasidenib8/6/2024Treatment of Grade 2 astrocytoma or oligodendrogliomaVoranigo VOYDEYAdanicopan3/29/2024To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuriaVoydeya VTAMAtapinarof12/7/2023Treatment of plaque psoriasisVtama VYLOYzolbetuximab-clzb10/18/2024To treat gastric or gastroesophageal junction adenocarcinomaVyloy WAINUAeplontersen12/21/2023To treat polyneuropathy of hereditary transthyretin-mediated amyloidosisWainua WINREVAIRsotatercept-csrk3/26/2024For the treatment of adults with pulmonary arterial hypertensionWinrevair XACDUROsulbactam for injection; durlobactam for injection5/23/2023Treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complexXacduro XDEMVYlotilaner ophthalmic solution7/24/2023To treat Demodex blepharitis, a type of eyelid infection. xdemvy XENOVIEWxenon Xe 129 hyperpolarized12/8/2023Evaluation of lung ventilation in adults and pediatric patientsXenoview XENPOZYMEolipudase alfa-rpcp8/31/2023To treat Acid Sphingomyelinase Deficiency[Xenpozyme](https://www.accessdata.fd