FDA novel drug approvals, 2024
Brand, generic name, approval date and the use the FDA approved it for. No recommendations. Updated 2026-10-12.
Weight loss & diabetesCancerBrain & mental healthInfections & vaccinesHeart & bloodImmune & inflammatoryKidney, liver & lungEyeWomen's & hormonal healthPain & anesthesiaDiagnostic & imaging agentsRare & geneticOther
AlyftrekKidney, liver & lung
vanzacaftor, tezacaftor, and deutivacaftor · Vertex Pharms Inc.For the treatment of cystic fibrosis (CF) in patients 6 years of age and olderAlhemoHeart & blood
concizumab-mtci · Novo Nordisk Inc.For routine prophylaxis to prevent bleeding episodes in hemophilia A and BTryngolzaWeight loss & diabetes
olezarsen · Ionis Pharms Inc.To treat familial chylomicronemia syndromeEnsacoveCancer
ensartinib · XcoveryTo treat non-small cell lung cancerUnloxcytCancer
cosibelimab-ipdlTo treat cutaneous squamous cell carcinomaCrenessityWomen's & hormonal health
crinecerfontTo treat classic congenital adrenal hyperplasiaBizengriCancer
zenocutuzumab-zbco · Merus N.V.To treat non-small cell lung cancer and pancreatic adenocarcinomaIomervuDiagnostic & imaging agents
iomeprol · BraccoFor use as a radiographic contrast agentAttrubyHeart & blood
acoramidis · Bridgebio PharmaTo treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosisRapiblykHeart & blood
landiolol · Aop Hlth UsTo treat supraventricular tachycardiaZiiheraCancer
zanidatamab-hrii · Jazz PharmsTo treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancerRevuforjCancer
revumenib · SyndaxTo treat relapsed or refractory acute leukemiaOrlynvahInfections & vaccines
sulopenem etzadroxil, probenecid · Iterum TherapTo treat uncomplicated urinary tract infections (uUTI)VyloyCancer
zolbetuximab-clzb · AstellasTo treat gastric or gastroesophageal junction adenocarcinomaHympavziHeart & blood
marstacimab-hncq · Pfizer Inc.To prevent or reduce bleeding episodes related to hemophilia A or BItovebiCancer
inavolisib · Genentech Inc.To treat locally advanced or metastatic breast cancerFlyrcadoHeart & blood
flurpiridaz F 18A radioactive diagnostic drug to evaluate for myocardial ischemia and infarctionCobenfyOther
xanomeline and trospium chloride · Bristol-MyersTo treat schizophreniaAqneursaRare & genetic
levacetylleucineTo treat Niemann-Pick disease type CMiplyffaRare & genetic
arimoclomol · Zevra DenmarkTo treat Niemann-Pick disease type CEbglyssImmune & inflammatory
lebrikizumab-lbkzTo treat moderate-to-severe atopic dermatitisLazcluzeCancer
lazertinib · Janssen BiotechTo treat non-small cell lung cancerLivdelziKidney, liver & lung
seladelpar · Gilead Sciences Inc.To treat primary biliary cholangitis (PBC)NiktimvoImmune & inflammatory
axatilimab-csfrTo treat chronic graft-versus-host disease (cGVHD)NemluvioImmune & inflammatory
nemolizumab-ilto · Galderma Labs LpTo treat prurigo nodularisYorvipathWomen's & hormonal health
palopegteriparatide · Ascendis Pharma BoneTo treat hypoparathyroidismVoranigoCancer
vorasidenibTo treat Grade 2 astrocytoma or oligodendrogliomaLeqselviImmune & inflammatory
deuruxolitinibTo treat severe alopecia areataKisunlaBrain & mental health
donanemab-azbt · Eli Lilly CoTo treat Alzheimer’s diseaseOhtuvayreImmune & inflammatory
ensifentrine · MsdTo treat chronic obstructive pulmonary diseasePiaskyHeart & blood
crovalimab-akkz · Genentech Inc.To treat paroxysmal nocturnal hemoglobinuriaSofdraOther
sofpironium · Botanix SbTo treat primary axillary hyperhidrosisIqirvoKidney, liver & lung
elafibranor · IpsenTo treat primary biliary cholangitis in combination with ursodeoxycholic acidRyteloCancer
imetelstat · GeronTo treat low- to intermediate-1 risk myelodysplastic syndromesImdelltraCancer
tarlatamab-dlleTo treat extensive stage small cell lung cancerXolremdiRare & genetic
mavorixafor · X4 PharmsTo treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis)OjemdaCancer
tovorafenib · Day One BiopharmsTo treat relapsed or refractory pediatric low-grade gliomaAnktivaCancer
nogapendekin alfa inbakicept-pmln · Altor Bioscience, LLC, An Indirect Wholly-Owned SuTo treat bladder cancerLumisightDiagnostic & imaging agents
pegulicianine · LumicellTo use as an optical imaging agent for the detection of cancerous tissueZevteraInfections & vaccines
ceftobiprole medocaril sodiumTo treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumoniaVoydeyaHeart & blood
danicopan · Alexion Pharms Inc.To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuriaVafseoHeart & blood
vadadustat · AkebiaTo treat anemia due to chronic kidney diseaseWinrevairHeart & blood
sotatercept-csrkTo treat pulmonary arterial hypertensionDuvyzatRare & genetic
givinostat · Italfarmaco SpaTo treat Duchenne muscular dystrophy in individuals aged 6 years and olderTryvioHeart & blood
aprocitentan · IdorsiaTo treat hypertensionRezdiffraKidney, liver & lung
resmetirom · MadrigalTo treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarringTevimbraCancer
tislelizumab-jsgrTo treat unresectable or metastatic esophageal squamous cell carcinomaLetyboOther
letibotulinumtoxinA-wlbg · Hugel Inc.To temporarily improve the appearance of moderate-to-severe glabellar linesExblifepInfections & vaccines
cefepime, enmetazobactamTo treat complicated urinary tract infectionsZelsuvmiOther
berdazimer · LnhcTo treat molluscum contagiosum