All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 2026
FDA approved the original submission of 80 new drug and biologics license applications in 2026, from 71 sponsors. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| MIMRYLO | rusfertide acetate | TAKEDA PHARMACEUTICALS U.S.A., INC. | NDA220605 | |
| BIXLENVO | bictegravir and lenacapavir | GILEAD SCIENCES | NDA221104 | |
| RASONQUE | daraxonrasib | REVOLUTION MEDICINES INC | NDA220910 | |
| VOBRIG | leuprolide acetate | SUN PHARMACEUTICAL INDUSTRIES LIMITED | NDA213225 | |
| PASATRU | garetosmab-grts | REGENERON PHARMACEUTICALS, INC | BLA761508 | |
| SODIUM BICARBONATE | sodium bicarbonate | BAXTER HLTHCARE CORP | NDA218524 | |
| TAUKLARIFY | florquinitau f-18 | CERVEAU LANTHEUS | NDA220496 | |
| ZENBEXUS | iberdomide hydrochloride | BRISTOL MYERS SQUIBB | NDA221075 | |
| NITROUS OXIDE, USP | nitrous oxide | LINDE GAS EQUIP | NDA221892 | |
| ORZEYFUL | oveporexton | TAKEDA PHARMS USA | NDA220860 | |
| ZIMRIXBY | rituximab-cdxx | DR REDDYS LABS SA | BLA761376 | |
| GLYCOPHOS | sodium glycerophosphate | FRESENIUS KABI USA | NDA220381 | |
| QLONILIK | clonidine hydrochloride | CMP DEV LLC | NDA221094 | |
| GWYN LO | ethinyl estradiol, norelgestromin | VIATRIS SPECIALTY | NDA219990 | |
| GARZULYS | insulin aspart-fsan | EMERGE BIOSCIENCE PTE. LTD. | BLA761497 | |
| LYTENAVA | bevacizumab-vikg | OUTLOOK THERAPEUTICS, INC. | BLA761320 | |
| SIMTRIYO | centanafadine hydrochloride | OTSUKA PHARMACEUTICAL CO LTD | NDA218145 | |
| TYLENOL WITH NAPROXEN | acetaminophen, naproxen sodium | KENVUE BRANDS | NDA219962 | |
| JIDEYTRO | zidesamtinib | NUVALENT | NDA220185 | |
| AIR | air | NOBLE GAS SOLUTIONS INC. | NDA221805 | |
| LIPFENDRA | enlicitide decanoate | MSD | NDA220848 | |
| REVTORPYK | gedatolisib | CELCUITY | NDA219908 | |
| ZYOGREEN | indocyanine green | PROVEPHARM SAS | NDA218579 | |
| SARCLISA ESCENA | isatuximab-irfc | SANOFI-AVENTIS U.S. LLC | BLA761445 | |
| SODIUM BICARBONATE | sodium bicarbonate | AMNEAL | NDA220790 | |
| TRUTAKNA | atacicept-vymj | VERA THERAPEUTICS INC. | BLA761486 | |
| LUMVOA | veligrotug-vvze | VIRIDIAN THERAPEUTICS INC | BLA761530 | |
| NAVITRUX | fosaprepitant dimeglumine | AVYXA HOLDINGS | NDA220436 | |
| UTEBZI | tebipenem pivoxil hydrobromide | GLAXOSMITHKLINE | NDA215960 | |
| APREPITANT | aprepitant | AZURITY | NDA218754 | |
| AMBELVIST | gadoquatrane | BAYER HEALTHCARE | NDA219627 | |
| RANLUSPEC | ranibizumab-hkdz | LUPIN LIMITED | BLA761480 | |
| TIOCYSTIN | tiopronin | CASPER PHARMA LLC | NDA212927 | |
| CAVHANZA | nilotinib | CYCLE | NDA217379 | |
| CIPEPOFOL | cipepofol | HAISCO PHARMACEUTICAL GROUP CO LTD | NDA220482 | |
| XOCOVA | ensitrelvir | SHIONOGI | NDA220442 | |
| ZAYNICH | cefepime hydrochloride, zidebactam | WOCKHARDT BIO AG | NDA220787 | |
| DECNUPAZ | pivekimab sunirine-pvzy | ABBVIE INC | BLA761460 | |
| DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | adapalene, benzoyl peroxide, adapalene, benzoyl peroxide | GALDERMA LABS LP | NDA220736 | |
| HEPCLUDEX | bulevirtide-gmod | GILEAD SCIENCES INC | BLA761468 | |
| BAXFENDY | baxdrostat | ASTRAZENECA AB | NDA219878 | |
| IMMGOLIS | golimumab-sldi | ACCORD BIOPHARMA INC. | BLA761452 | |
| TRIMBOW | beclomethasone dipropionate, formoterol fumarate, glycopyrrolate | CHIESI | NDA219622 | |
| BEQALZI | sonrotoclax | BEONE MEDICINES USA | NDA220711 | |
| ENNUMO | pegfilgrastim-pccg | ACCORD BIOPHARMA INC. | BLA761147 | |
| EVDI | trabectedin | APOTEX | NDA220837 | |
| JAKAFI XR | ruxolitinib phosphate | INCYTE CORP | NDA217180 | |
| VEPPANU | vepdegestrant | RIGEL PHARMS | NDA219835 | |
| LANGLARA | insulin glargine-aldy | SUNSHINE LAKE PHARMA CO LTD | BLA761412 | |
| SAPHNELO | anifrolumab-fnia | ASTRAZENECA AB | BLA761451 | |
| IDVYNSO | doravirine, islatravir | MSD | NDA216964 | |
| FOUNDAYO | orforglipron calcium | ELI LILLY AND CO | NDA220934 | |
| EPINEPHRINE | epinephrine | BAXTER HLTHCARE CORP | NDA220626 | |
| PONLIMSI | denosumab-adet | TEVA PHARMACEUTICALS, INC. | BLA761385 | |
| AWIQLI FLEXTOUCH | insulin icodec | NOVO NORDISK INC | BLA761326 | |
| LIFYORLI (COPACKAGED) | relacorilant | CORCEPT THERAP | NDA220641 | |
| AVLAYAH | tividenofusp alfa-eknm | DENALI THERAPEUTICS INC. | BLA761485 | |
| ATONCY | atomoxetine hydrochloride | MAP77 | NDA220320 | |
| FLAVALTA | epinephrine bitartrate, lidocaine hydrochloride | DEPROCO | NDA216564 | |
| ICOTYDE | icotrokinra hydrochloride | JANSSEN BIOTECH | NDA220149 | |
| LYNAVOY | linerixibat | INTERCEPT | NDA220295 | |
| PYLARIFY TRUVU | piflufolastat f-18 | APHELION | NDA220089 | |
| DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | ALMATICA | NDA219131 | |
| PREZCOBIX | darunavir and cobicistat, cobicistat, darunavir ethanolate | JANSSEN PRODS | NDA220092 | |
| YUVIWEL | navepegritide | ASCENDIS | NDA219164 | |
| DESMODA | desmopressin acetate | ETON | NDA219873 | |
| LOARGYS | pegzilarginase-nbln | IMMEDICA PHARMA AB | BLA761211 | |
| BYSANTI | milsaperidone | VANDA PHARMS INC | NDA220358 | |
| FAVLYXA | fluorouracil | AVYXA HOLDINGS | NDA220201 | |
| MEDICAL AIR, USP | — | INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC | NDA221337 | |
| AVOPEF | etoposide | AVYXA HOLDINGS | NDA220200 | |
| RYBREVANT FASPRO | amivantamab and hyaluronidase-lpuj | JANSSEN BIOTECH | BLA761484 | |
| ADQUEY | difamilast | ACROTECH BIOPHARMA | NDA219474 | |
| VYKOURA | leucovorin calcium | AVYXA HOLDINGS | NDA220406 | |
| AIR | air | GENERAL AIR SERVICE & SUPPLY COMPANY | NDA221287 | |
| YUVEZZI | brimonidine tartrate, carbachol | VISUS | NDA220142 | |
| QUIOFIC | folic acid | SOLUBIOMIX | NDA216395 | |
| AVTOZMA | tocilizumab-anoh | CELLTRION INC | BLA761498 | |
| FILKRI | filgrastim-laha | ACCORD BIOPHARMA INC. | BLA761027 | |
| ZYCUBO | copper histidinate | SENTYNL THERAPS INC | NDA211241 |