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Drugs

3,160 original NDA and BLA approvals since 1998, through Oct 29, 2026. Each opens the drug and its application history.

FDA has approved 47 new drugs this year, on pace for 57, the most since 2018

New molecular entities (Drugs@FDA Type 1) through Oct 29, 2026: 35 by this date last year, 47 in all of 2025. Shaded: the range of 2019–2025.

02957JanAprJulOct2026 pace 572025: 47

Worth knowing

New molecular entities approved in the 90 days to Oct 29, 2026

Approved after a complete response letter

  1. PixclaraFloretyrosine F-18 · TelixApproved Sep 11, 2026, letter Apr 25, 2025
  2. IsembyldApitegromab-Mstn · Scholar Rock IncApproved Sep 11, 2026, letter Sep 22, 2025

Priority review

  1. HibsagoBepirovirsen · Glaxosmithkline LLCApproved Oct 20, 2026
  2. HovilpriPritelivir Mesylate · Aicuris Anti-InfectApproved Oct 9, 2026
  3. EmcitateTiratricol · Rare ThyroidApproved Sep 28, 2026
  4. AtebriozZilurgisertib Fumarate · MirumApproved Sep 25, 2026
  5. LyrfigtuLirafugratinib Hydrochloride · ElevarApproved Sep 23, 2026

60 new molecular entities

ApprovedDrugSponsorKindApplication
Oct 20, 2026HibsagoBepirovirsenGlaxosmithkline LLCNew molecular entityPriority reviewNDA 221276
Oct 9, 2026HovilpriPritelivir MesylateAicuris Anti-InfectNew molecular entityPriority reviewNDA 221154
Sep 28, 2026EmcitateTiratricolRare ThyroidNew molecular entityPriority reviewNDA 220963
Sep 25, 2026JuvmoTavapadonAbbvieNew molecular entityNDA 220415
Sep 25, 2026AtebriozZilurgisertib FumarateMirumNew molecular entityPriority reviewNDA 221198
Sep 23, 2026LyrfigtuLirafugratinib HydrochlorideElevarNew molecular entityPriority reviewNDA 220425
Sep 23, 2026OnswikInsulin Efsitora Alfa-GobeEli Lilly And CoNew molecular entityBLA 761408
Sep 11, 2026PixclaraFloretyrosine F-18TelixNew molecular entityPriority reviewNDA 218592
Sep 11, 2026IsembyldApitegromab-MstnScholar Rock IncNew molecular entityPriority reviewBLA 761463
Sep 4, 2026EtcamahCamizestrantAstrazenecaNew molecular entityNDA 220359
Sep 3, 2026ZanvastroZilganersen SodiumIonis Pharms IncNew molecular entityPriority reviewNDA 220210
Aug 28, 2026MimryloRusfertide AcetateTakeda Pharms AmNew molecular entityPriority reviewNDA 220605
Aug 27, 2026LisrayaBrepocitinib TosylatePriovant TherapNew molecular entityPriority reviewNDA 220106
Aug 26, 2026RasonqueDaraxonrasibRevolution MedicinesNew molecular entityPriority reviewNDA 220910
Aug 19, 2026PasatruGaretosmab-GrtsRegeneron Pharmaceuticals, IncNew molecular entityPriority reviewBLA 761508
Aug 13, 2026TauklarifyFlorquinitau F-18Cerveau LantheusNew molecular entityNDA 220496
Aug 13, 2026ZenbexusIberdomide HydrochlorideBristol Myers SquibbNew molecular entityPriority reviewNDA 221075
Aug 5, 2026OrzeyfulOveporextonTakeda Pharms USANew molecular entityPriority reviewNDA 220860
Jul 24, 2026SimtriyoCentanafadine HydrochlorideOtsuka Pharmaceutical Co LtdNew molecular entityPriority reviewNDA 218145
Jul 24, 2026LytenavaBevacizumab-VikgOutlook Therapeutics, Inc.New molecular entity, new combinationBLA 761320
Jul 22, 2026JideytroZidesamtinibNuvalentNew molecular entityNDA 220185
Jul 15, 2026LipfendraEnlicitide DecanoateMsdNew molecular entityPriority reviewNDA 220848
Jul 14, 2026RevtorpykGedatolisibCelcuityNew molecular entityPriority reviewNDA 219908
Jul 7, 2026TrutaknaAtacicept-VymjVera Therapeutics Inc.New molecular entityPriority reviewBLA 761486
Jun 26, 2026LumvoaVeligrotug-VvzeViridian Therapeutics IncNew molecular entityPriority reviewBLA 761530
Jun 17, 2026UtebziTebipenem Pivoxil HydrobromideGlaxosmithklineNew molecular entityPriority reviewNDA 215960
Jun 12, 2026AmbelvistGadoquatraneBayer HealthcareNew molecular entityNDA 219627
May 29, 2026XocovaEnsitrelvirShionogiNew molecular entityNDA 220442
May 29, 2026CypsedoCipepofolHaiscoNew molecular entityNDA 220482
May 29, 2026ZaynichCefepime Hydrochloride; ZidebactamWockhardt Bio AGNew molecular entity, new combinationPriority reviewNDA 220787
May 27, 2026DecnupazPivekimab Sunirine-PvzyAbbvie IncNew molecular entityPriority reviewBLA 761460
May 22, 2026HepcludexBulevirtide-GmodGilead Sciences IncNew molecular entityPriority reviewBLA 761468
May 15, 2026BaxfendyBaxdrostatAstrazeneca ABNew molecular entityPriority reviewNDA 219878
May 13, 2026BeqalziSonrotoclaxBeone Medicines USANew molecular entityPriority reviewNDA 220711
May 1, 2026VeppanuVepdegestrantRigel PharmsNew molecular entityNDA 219835
Apr 20, 2026IdvynsoDoravirine; IslatravirMsdNew molecular entity, new combinationNDA 216964
Apr 1, 2026FoundayoOrforglipron CalciumEli Lilly And CoNew molecular entityNDA 220934
Mar 26, 2026Awiqli FlextouchInsulin IcodecNovo Nordisk IncNew molecular entityBLA 761326
Mar 25, 2026LifyorliRelacorilantCorcept TherapNew molecular entityNDA 220641
Mar 24, 2026AvlayahTividenofusp Alfa-EknmDenali Therapeutics Inc.New molecular entityPriority reviewBLA 761485
Mar 17, 2026IcotydeIcotrokinra HydrochlorideJanssen BiotechNew molecular entityPriority reviewNDA 220149
Mar 17, 2026LynavoyLinerixibatInterceptNew molecular entityNDA 220295
Feb 27, 2026YuviwelNavepegritideAscendisNew molecular entityPriority reviewNDA 219164
Feb 23, 2026LoargysPegzilarginase-NblnImmedica Pharma ABNew molecular entityPriority reviewBLA 761211
Feb 20, 2026BysantiMilsaperidoneVanda Pharms IncNew molecular entityNDA 220358
Feb 12, 2026AdqueyDifamilastAcrotech BiopharmaNew molecular entityNDA 219474
Jan 12, 2026ZycuboCopper HistidinateSentynl Theraps IncNew molecular entityPriority reviewNDA 211241
Dec 30, 2025NereusTradipitantVanda Pharms IncNew molecular entityNDA 220152
Dec 23, 2025YartemleaNarsoplimab-WuugOmeros CorpNew molecular entityPriority reviewBLA 761152
Dec 19, 2025MyqorzoAficamtenCytokineticsNew molecular entityNDA 219083
Dec 16, 2025ExdensurDepemokimab-UlaaGlaxosmithkline LLCNew molecular entityBLA 761458
Dec 12, 2025CardamystEtripamilMilestone Pharms USANew molecular entityNDA 218571
Dec 12, 2025NuzolvenceZoliflodacinEntasis TherapNew molecular entityPriority reviewNDA 219491
Dec 12, 2025LerocholLerodalcibep-LigaLib Therapeutics, Inc.New molecular entityBLA 761427
Nov 25, 2025VoyxactSibeprenlimab-SzsiOtsuka Pharm Co LtdNew molecular entityPriority reviewBLA 761434
Nov 19, 2025HyrnuoSevabertinibBayer HealthcareNew molecular entityPriority reviewNDA 219972
Nov 18, 2025RedemploPlozasiran SodiumArrowheadNew molecular entityNDA 219947
Nov 13, 2025KomziftiZiftomenibKuraNew molecular entityPriority reviewNDA 220305
Nov 3, 2025KygevviDoxecitine; DoxribtimineUcb IncNew molecular entityPriority reviewNDA 219792
Oct 24, 2025LynkuetElinzanetantBayer HlthcareNew molecular entityNDA 219469

Original approvals of new drug and biologic applications from FDA's Drugs@FDA data files, refreshed weekly. A new molecular entity is Drugs@FDA's Type 1 class. Drugs@FDA

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.