FDA Novel Drug Approvals
458 novel drugs approved 2016-2025, enriched with FDA CDER designation data.
Source: FDA CDER "Advancing Health Through Innovation" annual reports (10 years)
458
Novel Drugs
192
First-in-Class (42%)
233
Orphan Drug (51%)
141
Breakthrough (31%)
80
Accelerated Approval (17%)
278
Priority Review (61%)
179
Fast Track (39%)
Novel Drug Approvals by Year and Modality
Modality is classified from the generic name using INN suffix rules (e.g., -mab → antibody, -tide → peptide, -vedotin/-deruxtecan → ADC). Gene and cell therapies are called out separately so investors can see the advanced-modality share of novel approvals.
Small molecule (303)
Biologic (other) (82)
Antibody (21)
ADC (11)
Enzyme (11)
Peptide (10)
siRNA (8)
Bispecific antibody (7)
ASO (5)
Designation Rates by Year
Click any column header to sort. Default is by year (descending).
| Year | Total | First-in-Class | Orphan | Breakthrough | Accelerated | Priority Review | Fast Track |
|---|---|---|---|---|---|---|---|
| 2025 | 47 | 45% | 51% | 34% | 26% | 47% | 40% |
| 2024 | 50 | 48% | 52% | 36% | 14% | 56% | 44% |
| 2023 | 55 | 36% | 51% | 16% | 16% | 56% | 45% |
| 2022 | 37 | 54% | 54% | 35% | 16% | 57% | 32% |
| 2021 | 49 | 55% | 51% | 29% | 27% | 69% | 37% |
| 2020 | 50 | 36% | 62% | 42% | 22% | 58% | 34% |
| 2019 | 44 | 45% | 43% | 30% | 18% | 61% | 39% |
| 2018 | 58 | 33% | 59% | 24% | 7% | 74% | 41% |
| 2017 | 46 | 33% | 39% | 35% | 13% | 61% | 37% |
| 2016 | 22 | 36% | 36% | 32% | 18% | 68% | 36% |
All Novel Drugs
Year:
Designation:
Modality:
What do these designations mean?
First-in-Class
The drug uses a mechanism of action that no previously approved drug uses. It does not necessarily mean the drug is more effective - only that the mechanism is new.
Orphan Drug
Targets a rare disease affecting fewer than 200,000 people in the US. Grants 7 years of market exclusivity, tax credits, and fee waivers under the Orphan Drug Act.
Breakthrough Therapy
Early clinical evidence shows the drug may offer substantial improvement over existing treatments. The FDA provides intensive guidance, rolling review, and senior management involvement.
Accelerated Approval
Approved based on a surrogate endpoint (e.g., tumor shrinkage) rather than clinical outcome (e.g., survival). The company must run confirmatory trials post-approval.
Priority Review
FDA reviews the application in 6 months instead of the standard 10 months. Granted when the drug could provide a significant advance in treatment.
Fast Track
Enables rolling review (submit application sections as they're ready) and more frequent FDA communication. For drugs addressing unmet medical needs.
Most Decorated Drugs
by designation countTop drugs by number of FDA designations received (max 6). Reflects the current filter.
Top Companies
by novel approvalsCompanies ranked by count of novel drug approvals in the current filter.
Showing 458 of 458 drugs
| Drug | Year | Designations |
|---|---|---|
| ANDEMBRY garadacimab-gxii | 2025 | 1st-in-Class Orphan Fast Track |
| ANZUPGO delgocitinib | 2025 | Fast Track |
| AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) avutometinib potassium | 2025 | 1st-in-Class Orphan Breakthrough Accelerated Priority |
| BLENREP belantamab mafodotin-blmf | 2025 | 1st-in-Class Orphan Breakthrough Accelerated Priority |
| BLUJEPA gepotidacin mesylate | 2025 | 1st-in-Class Priority |
| BRINSUPRI brensocatib | 2025 | 1st-in-Class Priority |
| CARDAMYST etripamil | 2025 | |
| DATROWAY datopotamab deruxtecan-dlnk | 2025 | |
| DAWNZERA (AUTOINJECTOR) donidalorsen sodium | 2025 | 1st-in-Class Orphan |
| EKTERLY sebetralstat | 2025 | Orphan Fast Track |
| EMRELIS telisotuzumab vedotin-tllv | 2025 | 1st-in-Class Breakthrough Accelerated Priority |
| ENFLONSIA clesrovimab-cfor | 2025 | Fast Track |
| EXDENSUR depemokimab-ulaa | 2025 | |
| FORZINITY elamipretide hydrochloride | 2025 | 1st-in-Class Orphan Accelerated Priority Fast Track |
| GOMEKLI mirdametinib | 2025 | Orphan Priority Fast Track |
| GRAFAPEX treosulfan | 2025 | Orphan |
| HERNEXEOS zongertinib | 2025 | Breakthrough Accelerated Priority Fast Track |
| HYRNUO sevabertinib | 2025 | Orphan Breakthrough Accelerated Priority |
| IBTROZI taletrectinib adipate | 2025 | Orphan Breakthrough Priority |
| IMAAVY nipocalimab-aahu | 2025 | Orphan Priority Fast Track |
| INLURIYO imlunestrant tosylate | 2025 | Fast Track |
| JASCAYD nerandomilast | 2025 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| JOURNAVX suzetrigine | 2025 | 1st-in-Class Breakthrough Priority Fast Track |
| KEYTRUDA QLEX pembrolizumab | 2025 | Accelerated |
| KOMZIFTI ziftomenib | 2025 | Orphan Breakthrough Priority Fast Track |
| KYGEVVI doxecitine | 2025 | 1st-in-Class Orphan Breakthrough Priority |
| LEROCHOL lerodalcibep-liga | 2025 | |
| LYNKUET elinzanetant | 2025 | 1st-in-Class |
| LYNOZYFIC linvoseltamab-gcpt | 2025 | Orphan Accelerated Priority Fast Track |
| MODEYSO dordaviprone hydrochloride | 2025 | 1st-in-Class Orphan Accelerated Priority |
| MYQORZO aficamten | 2025 | Orphan Breakthrough |
| NEREUS tradipitant | 2025 | |
| NUZOLVENCE zoliflodacin | 2025 | 1st-in-Class Priority Fast Track |
| PALSONIFY paltusotine hydrochloride | 2025 | Orphan |
| PENPULIMAB-KCQX penpulimab-kcqx | 2025 | Orphan Breakthrough Fast Track |
| QFITLIA fitusiran sodium | 2025 | 1st-in-Class Orphan Fast Track |
| REDEMPLO plozasiran sodium | 2025 | 1st-in-Class Orphan Breakthrough Fast Track |
| RHAPSIDO remibrutinib | 2025 | 1st-in-Class |
| ROMVIMZA vimseltinib | 2025 | Priority Fast Track |
| SEPHIENCE sepiapterin | 2025 | Orphan |
| TRYPTYR acoltremon | 2025 | 1st-in-Class |
| VANRAFIA atrasentan hydrochloride | 2025 | Accelerated |
| VIZZ aceclidine hydrochloride | 2025 | |
| VOYXACT sibeprenlimab-szsi | 2025 | 1st-in-Class Breakthrough Accelerated Priority |
| WAYRILZ rilzabrutinib | 2025 | 1st-in-Class Orphan Fast Track |
| YARTEMLEA narsoplimab-wuug | 2025 | 1st-in-Class Orphan Breakthrough Priority |
| ZEGFROVY sunvozertinib | 2025 | Breakthrough Accelerated Priority |
| ALHEMO concizumab-mtci | 2024 | Orphan Priority |
| ALYFTREK deutivacaftor | 2024 | Orphan |
| ANKTIVA nogapendekin alfa inbakicept-pmln | 2024 | 1st-in-Class Breakthrough Fast Track |
| AQNEURSA levacetylleucine | 2024 | 1st-in-Class Orphan Priority Fast Track |
| ATTRUBY acoramidis hydrochloride | 2024 | Orphan |
| BIZENGRI zenocutuzumab-zbco | 2024 | 1st-in-Class Orphan Breakthrough Accelerated Priority Fast Track |
| COBENFY trospium chloride | 2024 | 1st-in-Class |
| CRENESSITY crinecerfont | 2024 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| DUVYZAT givinostat hydrochloride | 2024 | 1st-in-Class Orphan Priority Fast Track |
| EBGLYSS lebrikizumab-lbkz | 2024 | Fast Track |
| ENSACOVE ensartinib hydrochloride | 2024 | |
| EXBLIFEP cefepime hydrochloride | 2024 | Priority Fast Track |
| FLYRCADO flurpiridaz f-18 | 2024 | |
| HYMPAVZI marstacimab-hncq | 2024 | 1st-in-Class Orphan |
| IMDELLTRA tarlatamab-dlle | 2024 | 1st-in-Class Orphan Breakthrough Accelerated Priority |
| IOMERVU iomeprol | 2024 | |
| IQIRVO elafibranor | 2024 | 1st-in-Class Orphan Breakthrough Accelerated Priority |
| ITOVEBI inavolisib | 2024 | Breakthrough Priority |
| KISUNLA donanemab-azbt | 2024 | Breakthrough Priority Fast Track |
| LAZCLUZE lazertinib mesylate | 2024 | Priority |
| LEQSELVI deuruxolitinib phosphate | 2024 | Fast Track |
| LETYBO letibotulinumtoxina-wlbg | 2024 | |
| LIVDELZI seladelpar lysine | 2024 | Orphan Breakthrough Accelerated Priority |
| LUMISIGHT pegulicianine acetate | 2024 | 1st-in-Class Priority Fast Track |
| MIPLYFFA arimoclomol citrate | 2024 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| NEMLUVIO nemolizumab-ilto | 2024 | 1st-in-Class Breakthrough Priority |
| NIKTIMVO axatilimab-csfr | 2024 | 1st-in-Class Orphan Priority Fast Track |
| OHTUVAYRE ensifentrine | 2024 | |
| OJEMDA tovorafenib | 2024 | Orphan Breakthrough Accelerated Priority |
| ORLYNVAH probenecid | 2024 | Priority Fast Track |
| PIASKY crovalimab-akkz | 2024 | Orphan |
| RAPIBLYK landiolol hydrochloride | 2024 | |
| REVUFORJ revumenib citrate | 2024 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| REZDIFFRA resmetirom | 2024 | 1st-in-Class Breakthrough Accelerated Priority Fast Track |
| RYTELO imetelstat sodium | 2024 | 1st-in-Class Orphan Fast Track |
| SOFDRA sofpironium bromide | 2024 | |
| TEVIMBRA islelizumab-jsgr | 2024 | Orphan |
| TRYNGOLZA (AUTOINJECTOR) olezarsen sodium | 2024 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| TRYVIO aprocitentan | 2024 | 1st-in-Class |
| UNLOXCYT cosibelimab-ipdl | 2024 | |
| VAFSEO vadadustat | 2024 | |
| VORANIGO vorasidenib | 2024 | Orphan Breakthrough Priority Fast Track |
| VOYDEYA danicopan | 2024 | 1st-in-Class Orphan Breakthrough |
| VYLOY zolbetuximab-clzb | 2024 | 1st-in-Class Orphan Priority Fast Track |
| WINREVAIR sotatercept-csrk | 2024 | 1st-in-Class Orphan Breakthrough Priority |
| XOLREMDI mavorixafor | 2024 | 1st-in-Class Orphan Priority Fast Track |
| YORVIPATH palopegteriparatide | 2024 | Orphan Priority |
| ZELSUVMI berdazimer sodium | 2024 | 1st-in-Class |
| ZEVTERA ceftobiprole medocaril sodium | 2024 | Priority Fast Track |
| ZIIHERA zanidatamab-hrii | 2024 | 1st-in-Class Orphan Breakthrough Accelerated Priority Fast Track |
| AGAMREE vamorolone | 2023 | Orphan Fast Track |
| APHEXDA motixafortide acetate | 2023 | Orphan |
| AUGTYRO repotrectinib | 2023 | Orphan Priority |
| BEYFORTUS nirsevimab-alip | 2023 | Fast Track |
| BIMZELX bimekizumab-bkzx | 2023 | |
| BRENZAVVY bexagliflozin | 2023 | |
| COLUMVI glofitamab-gxbm | 2023 | Accelerated Priority Fast Track |
| DAYBUE trofinetide | 2023 | 1st-in-Class Orphan Priority Fast Track |
| DEFENCATH heparin sodium | 2023 | 1st-in-Class Priority Fast Track |
| ELFABRIO pegunigalsidase alfa-iwxj | 2023 | Priority Fast Track |
| ELREXFIO elranatamab | 2023 | Orphan Breakthrough Accelerated Priority Fast Track |
| EPKINLY epcoritamab-bysp | 2023 | Accelerated Priority |
| EXXUA gepirone hydrochloride | 2023 | |
| FABHALTA iptacopan hydrochloride | 2023 | 1st-in-Class Orphan Breakthrough |
| FILSPARI sparsentan | 2023 | 1st-in-Class Orphan Accelerated Priority |
| FILSUVEZ birch triterpenes | 2023 | 1st-in-Class Orphan Priority Fast Track |
| FRUZAQLA fruquintinib | 2023 | Priority Fast Track |
| INPEFA sotagliflozin | 2023 | |
| IZERVAY avacincaptad pegol sodium | 2023 | Breakthrough Priority Fast Track |
| JAYPIRCA pirtobrutinib | 2023 | Orphan Accelerated Priority Fast Track |
| JESDUVROQ daprodustat | 2023 | 1st-in-Class |
| JOENJA leniolisib phosphate | 2023 | 1st-in-Class Orphan Priority |
| LAMZEDE velmanase alfa-tycv | 2023 | 1st-in-Class Orphan Priority Fast Track |
| LEQEMBI lecanemab-irmb | 2023 | Breakthrough Accelerated Priority Fast Track |
| LITFULO ritlecitinib tosylate | 2023 | |
| LOQTORZI toripalimab-tpzi | 2023 | Orphan Breakthrough Priority |
| MIEBO perfluorohexyloctane | 2023 | 1st-in-Class |
| NGENLA somatrogon-ghla | 2023 | Orphan |
| OGSIVEO nirogacestat hydrobromide | 2023 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| OJJAARA momelotinib dihydrochloride | 2023 | Orphan |
| OMVOH mirikizumab-mrkz | 2023 | |
| ORSERDU elacestrant hydrochloride | 2023 | Priority Fast Track |
| PAXLOVID (COPACKAGED) nirmatrelvir | 2023 | 1st-in-Class Priority Fast Track |
| POMBILITI cipaglucosidase alfa-atga | 2023 | Orphan Breakthrough |
| POSLUMA flotufolastat f-18 gallium | 2023 | |
| QALSODY tofersen | 2023 | 1st-in-Class Orphan Accelerated Priority Fast Track |
| REZZAYO rezafungin acetate | 2023 | Orphan Priority Fast Track |
| RIVFLOZA nedosiran sodium | 2023 | 1st-in-Class Orphan Breakthrough |
| RYSTIGGO rozanolixizumab-noli | 2023 | Orphan Priority |
| RYZNEUTA efbemalenograstim alfa-vuxw | 2023 | |
| SKYCLARYS omaveloxolone | 2023 | 1st-in-Class Orphan Priority Fast Track |
| SOHONOS palovarotene | 2023 | 1st-in-Class Orphan Priority |
| TALVEY talquetamab-tgvs | 2023 | 1st-in-Class Orphan Breakthrough Accelerated Priority |
| TRUQAP capivasertib | 2023 | 1st-in-Class Priority Fast Track |
| VANFLYTA quizartinib dihydrochloride | 2023 | Orphan Priority Fast Track |
| VELSIPITY etrasimod arginine | 2023 | |
| VEOPOZ pozelimab-bbfg | 2023 | 1st-in-Class Orphan Priority Fast Track |
| VEOZAH fezolinetant | 2023 | 1st-in-Class |
| WAINUA (AUTOINJECTOR) eplontersen sodium | 2023 | Orphan |
| XACDURO (COPACKAGED) durlobactam sodium | 2023 | Priority Fast Track |
| XDEMVY lotilaner | 2023 | 1st-in-Class |
| ZAVZPRET zavegepant hydrochloride | 2023 | |
| ZILBRYSQ zilucoplan sodium | 2023 | Orphan |
| ZURZUVAE zuranolone | 2023 | Priority Fast Track |
| ZYNYZ retifanlimab-dlwr | 2023 | Orphan Accelerated Priority Fast Track |
| AMVUTTRA vutrisiran sodium | 2022 | Orphan Fast Track |
| BRIUMVI ublituximab-xiiy | 2022 | Orphan |
| CAMZYOS mavacamten | 2022 | 1st-in-Class Orphan Breakthrough |
| CIBINQO abrocitinib | 2022 | Breakthrough Priority |
| DAXXIFY daxibotulinumtoxina-lanm | 2022 | |
| ELAHERE mirvetuximab soravtansine-gynx | 2022 | 1st-in-Class Orphan Accelerated Priority Fast Track |
| ELUCIREM gadopiclenol | 2022 | Priority |
| ENJAYMO sutimlimab-jome | 2022 | 1st-in-Class Orphan Breakthrough Priority |
| IMJUDO tremelimumab-actl | 2022 | Orphan |
| KIMMTRAK tebentafusp-tebn | 2022 | 1st-in-Class Orphan Breakthrough Priority |
| KRAZATI adagrasib | 2022 | Orphan Breakthrough Accelerated Fast Track |
| LUNSUMIO mosunetuzumab-axgb | 2022 | 1st-in-Class Orphan Breakthrough Accelerated Priority |
| LYTGOBI futibatinib | 2022 | Orphan Breakthrough Accelerated Priority Fast Track |
| MOUNJARO tirzepatide | 2022 | 1st-in-Class |
| NEXOBRID anacaulase-bcdb | 2022 | |
| OMLONTI omidenepag isopropyl | 2022 | |
| OPDUALAG nivolumab | 2022 | 1st-in-Class Orphan Priority Fast Track |
| PLUVICTO lutetium lu-177 vipivotide tetraxetan | 2022 | 1st-in-Class Orphan Breakthrough Priority |
| PYRUKYND mitapivat sulfate | 2022 | 1st-in-Class Orphan Priority Fast Track |
| QUVIVIQ daridorexant hydrochloride | 2022 | |
| RELYVRIO sodium phenylbutyrate | 2022 | Orphan Priority |
| REZLIDHIA olutasidenib | 2022 | |
| ROLVEDON eflapegrastim-xnst | 2022 | |
| SOTYKTU deucravacitinib | 2022 | 1st-in-Class |
| SPEVIGO spesolimab-sbzo | 2022 | 1st-in-Class Orphan Breakthrough Priority |
| SUNLENCA lenacapavir sodium | 2022 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| TECVAYLI teclistamab-cqyv | 2022 | 1st-in-Class Orphan Breakthrough Accelerated Priority |
| TERLIVAZ terlipressin acetate | 2022 | 1st-in-Class Orphan Priority Fast Track |
| TZIELD teplizumab-mzwv | 2022 | 1st-in-Class Breakthrough Priority |
| VABYSMO faricimab-svoa | 2022 | |
| VIVJOA oteseconazole | 2022 | Priority Fast Track |
| VONJO pacritinib citrate | 2022 | Orphan Accelerated Priority Fast Track |
| VOQUEZNA TRIPLE PAK amoxicillin | 2022 | 1st-in-Class Priority Fast Track |
| VTAMA tapinarof | 2022 | 1st-in-Class |
| XENOVIEW xenon xe-129 hyperpolarized | 2022 | 1st-in-Class |
| XENPOZYME olipudase alfa-rpcp | 2022 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| ZTALMY ganaxolone | 2022 | 1st-in-Class Priority |
| ADBRY tralokinumab | 2021 | 1st-in-Class |
| ADUHELM aducanumab-avwa | 2021 | 1st-in-Class Accelerated Priority Fast Track |
| AMONDYS 45 casimersen | 2021 | Orphan Accelerated Priority Fast Track |
| AZSTARYS dexmethylphenidate hydrochloride | 2021 | |
| BESREMI ropeginterferon alfa-2b-njft | 2021 | 1st-in-Class Orphan |
| BREXAFEMME ibrexafungerp citrate | 2021 | 1st-in-Class Priority Fast Track |
| BYLVAY odevixibat | 2021 | 1st-in-Class Orphan Priority Fast Track |
| CABENUVA KIT cabotegravir | 2021 | Priority Fast Track |
| COSELA trilaciclib dihydrochloride | 2021 | 1st-in-Class Breakthrough Priority |
| CYTALUX pafolacianine sodium | 2021 | 1st-in-Class Orphan Priority Fast Track |
| EMPAVELI pegcetacoplan | 2021 | 1st-in-Class Orphan Priority Fast Track |
| EVKEEZA evinacumab-dgnb | 2021 | 1st-in-Class Orphan Breakthrough Priority |
| EXKIVITY mobocertinib succinate | 2021 | Orphan Breakthrough Accelerated Priority Fast Track |
| FEXINIDAZOLE fexinidazole | 2021 | Orphan Priority |
| FOTIVDA tivozanib hydrochloride | 2021 | |
| JEMPERLI dostarlimab-gxly | 2021 | Breakthrough Accelerated Priority |
| KERENDIA finerenone | 2021 | 1st-in-Class Priority Fast Track |
| KORSUVA difelikefalin acetate | 2021 | 1st-in-Class Breakthrough Priority |
| LEQVIO inclisiran sodium | 2021 | 1st-in-Class Priority |
| LIVMARLI maralixibat chloride | 2021 | Orphan Breakthrough Priority |
| LIVTENCITY maribavir | 2021 | 1st-in-Class Orphan Breakthrough Priority |
| LUMAKRAS sotorasib | 2021 | 1st-in-Class Orphan Breakthrough Accelerated Priority Fast Track |
| LUPKYNIS voclosporin | 2021 | 1st-in-Class Priority Fast Track |
| LYBALVI olanzapine | 2021 | |
| NEXTSTELLIS drospirenone | 2021 | |
| NEXVIAZYME avalglucosidase alfa-ngpt | 2021 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| NULIBRY fosdenopterin hydrobromide | 2021 | 1st-in-Class Orphan Breakthrough Priority |
| PONVORY ponesimod | 2021 | |
| PYLARIFY piflufolastat f-18 | 2021 | Priority |
| QELBREE viloxazine hydrochloride | 2021 | |
| QULIPTA atogepant | 2021 | |
| REZUROCK belumosudil mesylate | 2021 | 1st-in-Class Orphan Breakthrough Priority |
| RYBREVANT amivantamab-vmjw | 2021 | 1st-in-Class Breakthrough Accelerated Priority |
| RYLAZE asparaginase erwinia chrysanthemi (recombinant)-rywn | 2021 | Orphan Fast Track |
| SAPHNELO anifrolumab-fnia | 2021 | 1st-in-Class Fast Track |
| SCEMBLIX asciminib hydrochloride | 2021 | Orphan Breakthrough Accelerated Priority Fast Track |
| SKYTROFA lonapegsomatropin-tcgd | 2021 | Orphan |
| TAVNEOS avacopan | 2021 | Orphan |
| TEPMETKO tepotinib hydrochloride | 2021 | Orphan Accelerated Priority |
| TEZSPIRE tezepelumab-ekko | 2021 | 1st-in-Class Priority |
| TIVDAK tisotumab vedotin-tftv | 2021 | 1st-in-Class Accelerated Priority |
| TRUSELTIQ infigratinib phosphate | 2021 | Orphan Accelerated Priority Fast Track |
| UKONIQ umbralisib tosylate | 2021 | Orphan Breakthrough Accelerated Priority |
| VERQUVO vericiguat | 2021 | 1st-in-Class Priority Fast Track |
| VOXZOGO vosoritide | 2021 | 1st-in-Class Orphan Accelerated Priority |
| VYVGART efgartigimod alfa | 2021 | 1st-in-Class Orphan Fast Track |
| WELIREG belzutifan | 2021 | 1st-in-Class Orphan Priority |
| ZEGALOGUE dasiglucagon hydrochloride | 2021 | |
| ZYNLONTA loncastuximab tesirine-lpyl | 2021 | 1st-in-Class Orphan Accelerated Priority |
| ARTESUNATE artesunate | 2020 | Orphan Breakthrough Priority Fast Track |
| AYVAKIT avapritinib | 2020 | Orphan Breakthrough Priority Fast Track |
| BARHEMSYS amisulpride | 2020 | |
| BYFAVO remimazolam besylate | 2020 | |
| CERIANNA fluoroestradiol f-18 | 2020 | |
| DANYELZA naxitamab-gqgk | 2020 | Orphan Breakthrough Accelerated Priority |
| DETECTNET copper cu-64 dotatate | 2020 | Orphan Priority Fast Track |
| DOJOLVI triheptanoin | 2020 | Orphan Fast Track |
| EBANGA ansuvimab-zykl | 2020 | Orphan Breakthrough Priority |
| ENSPRYNG satralizumab | 2020 | 1st-in-Class Orphan Breakthrough Fast Track |
| EVRYSDI risdiplam | 2020 | Orphan Priority Fast Track |
| GAVRETO pralsetinib | 2020 | Orphan Breakthrough Accelerated Priority |
| GEMTESA vibegron | 2020 | |
| IMCIVREE setmelanotide acetate | 2020 | 1st-in-Class Orphan Breakthrough Priority |
| INMAZEB atoltivimab | 2020 | 1st-in-Class Orphan Breakthrough Priority |
| INQOVI cedazuridine | 2020 | Orphan Priority |
| ISTURISA osilodrostat phosphate | 2020 | 1st-in-Class Orphan |
| KLISYRI tirbanibulin | 2020 | 1st-in-Class |
| KOSELUGO selumetinib | 2020 | 1st-in-Class Orphan Breakthrough Priority |
| LAMPIT nifurtimox | 2020 | Orphan Accelerated Priority |
| MARGENZA margetuximab-cmkb | 2020 | Fast Track |
| MONJUVI tafasitamab-cxix | 2020 | 1st-in-Class Orphan Breakthrough Accelerated Priority Fast Track |
| NEXLETOL bempedoic acid | 2020 | 1st-in-Class |
| NURTEC ODT rimegepant sulfate | 2020 | |
| OLINVYK oliceridine | 2020 | Fast Track |
| ONGENTYS opicapone | 2020 | |
| ORGOVYX relugolix | 2020 | Priority |
| ORLADEYO berotralstat dihydrochloride | 2020 | Orphan Fast Track |
| OXLUMO lumasiran sodium | 2020 | 1st-in-Class Orphan Breakthrough Priority |
| PEMAZYRE pemigatinib | 2020 | Orphan Breakthrough Accelerated Priority |
| PIZENSY lactitol | 2020 | |
| QINLOCK ripretinib | 2020 | Orphan Breakthrough Priority Fast Track |
| RETEVMO selpercatinib | 2020 | Orphan Breakthrough Accelerated Priority |
| RUKOBIA fostemsavir tromethamine | 2020 | 1st-in-Class Breakthrough Priority Fast Track |
| SARCLISA isatuximab-irfc | 2020 | Orphan |
| SOGROYA somapacitan-beco | 2020 | |
| TABRECTA capmatinib hydrochloride | 2020 | Orphan Breakthrough Accelerated Priority |
| TAUVID flortaucipir f-18 | 2020 | 1st-in-Class Priority |
| TAZVERIK tazemetostat hydrobromide | 2020 | 1st-in-Class Orphan Accelerated Priority |
| TEPEZZA teprotumumab-trbw | 2020 | Orphan Breakthrough Priority Fast Track |
| TRODELVY sacituzumab govitecan-hziy | 2020 | 1st-in-Class Orphan Breakthrough Accelerated Priority Fast Track |
| TUKYSA tucatinib | 2020 | Orphan Breakthrough Priority Fast Track |
| UPLIZNA inebilizumab-cdon | 2020 | 1st-in-Class Orphan Breakthrough |
| VEKLURY remdesivir | 2020 | 1st-in-Class Priority Fast Track |
| VILTEPSO viltolarsen | 2020 | Orphan Accelerated Priority Fast Track |
| WINLEVI clascoterone | 2020 | 1st-in-Class |
| XEGLYZE abametapir | 2020 | 1st-in-Class |
| ZEPOSIA ozanimod hydrochloride | 2020 | |
| ZEPZELCA lurbinectedin | 2020 | Orphan Accelerated Priority |
| ZOKINVY lonafarnib | 2020 | 1st-in-Class Orphan Breakthrough Priority |
| ACCRUFER ferric maltol | 2019 | |
| ADAKVEO crizanlizumab-tmca | 2019 | 1st-in-Class Orphan Breakthrough Priority |
| AKLIEF trifarotene | 2019 | |
| BALVERSA erdafitinib | 2019 | 1st-in-Class Breakthrough Accelerated Priority |
| BEOVU brolucizumab-dbll | 2019 | |
| BRUKINSA zanubrutinib | 2019 | Orphan Breakthrough Accelerated Priority |
| CABLIVI caplacizumab-yhdp | 2019 | 1st-in-Class Orphan Priority Fast Track |
| CAPLYTA lumateperone tosylate | 2019 | Fast Track |
| DAYVIGO lemborexant | 2019 | |
| EGATEN triclabendazole | 2019 | Orphan Priority Fast Track |
| ENHERTU fam-trastuzumab deruxtecan-nxki | 2019 | Breakthrough Accelerated Priority Fast Track |
| EVENITY romosozumab-aqqg | 2019 | 1st-in-Class |
| FETROJA cefiderocol sulfate tosylate | 2019 | Priority Fast Track |
| GIVLAARI givosiran sodium | 2019 | 1st-in-Class Orphan Breakthrough Priority |
| IBSRELA tenapanor hydrochloride | 2019 | 1st-in-Class |
| INREBIC fedratinib hydrochloride | 2019 | Orphan Priority |
| JEUVEAU prabotulinumtoxina-xvfs | 2019 | |
| MAYZENT siponimod | 2019 | |
| NOURIANZ istradefylline | 2019 | 1st-in-Class |
| NUBEQA darolutamide | 2019 | Priority Fast Track |
| OXBRYTA voxelotor | 2019 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| PADCEV enfortumab vedotin-ejfv | 2019 | 1st-in-Class Breakthrough Accelerated Priority |
| PIQRAY alpelisib | 2019 | Priority |
| POLIVY polatuzumab vedotin-piiq | 2019 | 1st-in-Class Orphan Breakthrough Accelerated Priority |
| PRETOMANID pretomanid | 2019 | 1st-in-Class Orphan Priority Fast Track |
| REBLOZYL luspatercept-aamt | 2019 | 1st-in-Class Orphan Priority Fast Track |
| RECARBRIO cilastatin sodium | 2019 | Priority Fast Track |
| REYVOW lasmiditan succinate | 2019 | 1st-in-Class |
| RINVOQ upadacitinib | 2019 | |
| ROZLYTREK entrectinib | 2019 | Orphan Breakthrough Accelerated Priority |
| SCENESSE afamelanotide | 2019 | 1st-in-Class Orphan Priority Fast Track |
| SKYRIZI risankizumab-rzaa | 2019 | |
| SUNOSI solriamfetol hydrochloride | 2019 | Orphan |
| TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor | 2019 | Orphan Breakthrough Priority Fast Track |
| TURALIO pexidartinib hydrochloride | 2019 | 1st-in-Class Orphan Breakthrough Priority |
| UBRELVY ubrogepant | 2019 | |
| VYLEESI (AUTOINJECTOR) bremelanotide acetate | 2019 | 1st-in-Class |
| VYNDAQEL tafamidis meglumine | 2019 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| VYONDYS 53 golodirsen | 2019 | Orphan Accelerated Priority Fast Track |
| WAKIX pitolisant hydrochloride | 2019 | 1st-in-Class Orphan Priority Fast Track |
| XCOPRI cenobamate | 2019 | |
| XENLETA lefamulin acetate | 2019 | Priority Fast Track |
| XPOVIO selinexor | 2019 | 1st-in-Class Orphan Accelerated Priority Fast Track |
| ZULRESSO brexanolone | 2019 | 1st-in-Class Breakthrough Priority |
| AEMCOLO rifamycin sodium | 2018 | Priority Fast Track |
| AIMOVIG erenumab-aooe | 2018 | 1st-in-Class |
| AJOVY fremanezumab-vfrm | 2018 | Priority |
| ANNOVERA ethinyl estradiol | 2018 | |
| ASPARLAS calaspargase pegol-mknl | 2018 | Orphan |
| BIKTARVY bictegravir sodium | 2018 | Priority |
| BRAFTOVI encorafenib | 2018 | Orphan |
| COPIKTRA duvelisib | 2018 | Orphan Accelerated Priority Fast Track |
| CRYSVITA burosumab-twza | 2018 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| DAURISMO glasdegib maleate | 2018 | Orphan Priority |
| DIACOMIT stiripentol | 2018 | Orphan Priority |
| DOPTELET avatrombopag maleate | 2018 | Priority |
| ELZONRIS tagraxofusp-erzs | 2018 | 1st-in-Class Orphan Breakthrough Priority |
| EMGALITY galcanezumab-gnlm | 2018 | Priority |
| EPIDIOLEX cannabidiol | 2018 | Orphan Priority Fast Track |
| ERLEADA apalutamide | 2018 | Priority Fast Track |
| FIRDAPSE amifampridine phosphate | 2018 | Orphan Breakthrough Priority |
| GALAFOLD migalastat hydrochloride | 2018 | 1st-in-Class Orphan Accelerated Priority Fast Track |
| GAMIFANT emapalumab-lzsg | 2018 | 1st-in-Class Orphan Breakthrough Priority |
| ILUMYA tildrakizumab-asmn | 2018 | |
| KRINTAFEL tafenoquine succinate | 2018 | Orphan Breakthrough Priority |
| LIBTAYO cemiplimab-rwlc | 2018 | Breakthrough Priority |
| LOKELMA sodium zirconium cyclosilicate | 2018 | |
| LORBRENA lorlatinib | 2018 | Orphan Breakthrough Accelerated Priority |
| LUCEMYRA lofexidine hydrochloride | 2018 | 1st-in-Class Priority Fast Track |
| LUMOXITI moxetumomab pasudotox-tdfk | 2018 | Orphan Priority Fast Track |
| LUTATHERA lutetium lu 177 dotatate | 2018 | 1st-in-Class Orphan Priority Fast Track |
| MEKTOVI binimetinib | 2018 | Orphan |
| MOTEGRITY prucalopride succinate | 2018 | |
| MOXIDECTIN moxidectin | 2018 | Orphan Priority |
| MULPLETA lusutrombopag | 2018 | Priority Fast Track |
| NUZYRA omadacycline tosylate | 2018 | Priority Fast Track |
| OLUMIANT baricitinib | 2018 | |
| OMEGAVEN fish oil triglycerides | 2018 | Orphan Priority Fast Track |
| ONPATTRO patisiran sodium | 2018 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| ORILISSA elagolix sodium | 2018 | 1st-in-Class Priority |
| OXERVATE cenegermin-bkbj | 2018 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| PALYNZIQ pegvaliase-pqpz | 2018 | 1st-in-Class Orphan Priority Fast Track |
| PIFELTRO doravirine | 2018 | |
| POTELIGEO mogamulizumab-kpkc | 2018 | 1st-in-Class Orphan Breakthrough Priority |
| REVCOVI elapegademase-lvlr | 2018 | Orphan Priority Fast Track |
| SEYSARA sarecycline hydrochloride | 2018 | |
| SYMDEKO (COPACKAGED) ivacaftor | 2018 | Orphan Breakthrough Priority Fast Track |
| TAKHZYRO lanadelumab-flyo | 2018 | Orphan Breakthrough Priority Fast Track |
| TALZENNA talazoparib tosylate | 2018 | Priority |
| TAVALISSE fostamatinib disodium | 2018 | 1st-in-Class Orphan |
| TEGSEDI inotersen sodium | 2018 | 1st-in-Class Orphan Priority Fast Track |
| TIBSOVO ivosidenib | 2018 | 1st-in-Class Orphan Priority Fast Track |
| TPOXX tecovirimat | 2018 | 1st-in-Class Orphan Priority Fast Track |
| TROGARZO ibalizumab-uiyk | 2018 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| ULTOMIRIS ravulizumab-cwvz | 2018 | Orphan |
| VITRAKVI larotrectinib sulfate | 2018 | 1st-in-Class Orphan Breakthrough Accelerated Priority |
| VIZIMPRO dacomitinib | 2018 | Orphan Priority |
| XERAVA eravacycline dihydrochloride | 2018 | Priority Fast Track |
| XOFLUZA baloxavir marboxil | 2018 | 1st-in-Class Priority |
| XOSPATA gilteritinib fumarate | 2018 | Orphan Priority Fast Track |
| YUPELRI revefenacin | 2018 | |
| ZEMDRI plazomicin sulfate | 2018 | |
| ALIQOPA copanlisib dihydrochloride | 2017 | Orphan Accelerated Priority Fast Track |
| ALUNBRIG brigatinib | 2017 | Orphan Breakthrough Accelerated Priority |
| AUSTEDO deutetrabenazine | 2017 | Orphan |
| BAVENCIO avelumab | 2017 | Orphan Breakthrough Accelerated Priority Fast Track |
| BAXDELA delafloxacin meglumine | 2017 | Priority Fast Track |
| BENZNIDAZOLE benznidazole | 2017 | Orphan Accelerated Priority |
| BESPONSA inotuzumab ozogamicin | 2017 | 1st-in-Class Orphan Breakthrough Priority |
| BEVYXXA betrixaban | 2017 | Priority Fast Track |
| BRINEURA cerliponase alfa | 2017 | 1st-in-Class Orphan Breakthrough Priority |
| CALQUENCE acalabrutinib maleate | 2017 | Orphan Breakthrough Accelerated Priority |
| DUPIXENT dupilumab | 2017 | 1st-in-Class Breakthrough Priority |
| EMFLAZA deflazacort | 2017 | 1st-in-Class Orphan Priority Fast Track |
| FASENRA benralizumab | 2017 | |
| GIAPREZA angiotensin ii acetate | 2017 | 1st-in-Class Priority |
| HEMLIBRA emicizumab | 2017 | 1st-in-Class Orphan Breakthrough Priority |
| IDHIFA enasidenib mesylate | 2017 | 1st-in-Class Orphan Priority Fast Track |
| IMFINZI durvalumab | 2017 | Breakthrough Accelerated Priority |
| INGREZZA valbenazine tosylate | 2017 | Breakthrough Priority Fast Track |
| KEVZARA sarilumab | 2017 | |
| KISQALI ribociclib succinate | 2017 | Breakthrough Priority |
| MACRILEN macimorelin acetate | 2017 | 1st-in-Class Orphan |
| MAVYRET glecaprevir | 2017 | Breakthrough Priority Fast Track |
| MEPSEVII vestronidase alfa-vjbk | 2017 | 1st-in-Class Orphan Priority Fast Track |
| NERLYNX neratinib maleate | 2017 | |
| OCREVUS ocrelizumab | 2017 | 1st-in-Class Breakthrough Priority Fast Track |
| OZEMPIC semaglutide | 2017 | |
| PARSABIV etelcalcetide | 2017 | |
| PREVYMIS letermovir | 2017 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| RADICAVA edaravone | 2017 | 1st-in-Class Orphan |
| RHOPRESSA netarsudil mesylate | 2017 | 1st-in-Class |
| RYDAPT midostaurin | 2017 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| SILIQ brodalumab | 2017 | |
| SOLOSEC secnidazole | 2017 | Priority Fast Track |
| STEGLATRO ertugliflozin | 2017 | |
| SYMPROIC naldemedine tosylate | 2017 | |
| TREMFYA guselkumab | 2017 | |
| TRULANCE plecanatide | 2017 | |
| TYMLOS abaloparatide | 2017 | |
| VABOMERE meropenem | 2017 | Priority Fast Track |
| VERZENIO abemaciclib | 2017 | Priority Fast Track |
| VOSEVI sofosbuvir | 2017 | Breakthrough Priority |
| VYZULTA latanoprostene bunod | 2017 | |
| XADAGO safinamide mesylate | 2017 | |
| XEPI ozenoxacin | 2017 | |
| XERMELO telotristat etiprate | 2017 | 1st-in-Class Orphan Priority Fast Track |
| ZEJULA niraparib tosylate | 2017 | Orphan Breakthrough Priority Fast Track |
| ADLYXIN lixisenatide | 2016 | Priority |
| ANTHIM obiltoxaximab | 2016 | Priority |
| AXUMIN fluciclovine f-18 | 2016 | |
| BRIVIACT brivaracetam | 2016 | Priority |
| CINQAIR reslizumab | 2016 | 1st-in-Class |
| DEFITELIO defibrotide sodium | 2016 | 1st-in-Class Orphan Priority Fast Track |
| EPCLUSA sofosbuvir | 2016 | Breakthrough Priority Fast Track |
| EUCRISA crisaborole | 2016 | |
| EXONDYS 51 eteplirsen | 2016 | Orphan Accelerated Priority Fast Track |
| LARTRUVO olaratumab | 2016 | Orphan Breakthrough Accelerated Priority |
| NETSPOT gallium dotatate ga-68 | 2016 | |
| NUPLAZID pimavanserin tartrate | 2016 | 1st-in-Class Orphan Breakthrough Priority |
| OCALIVA obeticholic acid | 2016 | Orphan Priority |
| RUBRACA rucaparib camsylate | 2016 | 1st-in-Class Orphan Breakthrough Priority Fast Track |
| SPINRAZA nusinersen sodium | 2016 | 1st-in-Class Orphan Priority Fast Track |
| TALTZ ixekizumab | 2016 | |
| TECENTRIQ atezolizumab | 2016 | 1st-in-Class Breakthrough Accelerated Priority Fast Track |
| VENCLEXTA venetoclax | 2016 | 1st-in-Class Orphan Breakthrough Accelerated Priority Fast Track |
| XIIDRA lifitegrast | 2016 | |
| ZEPATIER elbasvir | 2016 | Breakthrough Priority Fast Track |
| ZINBRYTA daclizumab | 2016 | Priority |
| ZINPLAVA bezlotoxumab | 2016 | 1st-in-Class |
No drugs match the selected filters.