New FDA Approved
Specialty Drugs

Zycubo (copper histidinate); Sentynl Therapeutics, Inc.; To treat Menkes disease, Approved January 2026

Adquey (difamilast); Acrotech Biopharma Inc.; To treat mild to moderate atopic dermatitis, Approved February 2026

Bysanti (milsaperidone); Vanda Pharmaceuticals, Inc.; To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder, Approved February 2026

Loargys (pegzilarginase-nbln); Immedica Pharma AB; To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction, Approved February 2026

Yuviwel (navepegritide); Ascendis Pharma Growth Disorders (A/S); To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses, Approved February 2026

Lynavoy (linerixibat); GlaxoSmithKline LLC (GSK); To treat cholestatic pruritus associated with primary biliary cholangitis, Approved March 2026

Icotyde (icotrokinra); Johnson & Johnson; To treat moderate-to-severe plaque psoriasis in patients 12 years and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy, Approved March 2026

Datroway (datopotamab deruxtecan-dlnk); Daiichi Sankyo, Inc.; To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease, Approved January 2025

Grafapex (treosulfan); Medexus Pharma Inc; For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome, Approved January 2025

Journavx (suzetrigine); Vertex Pharmaceuticals Inc; To treat moderate to severe acute pain, Approved January 2025

Gomekli (mirdametinib); SpringWorks Therapeutics Inc; To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection, Approved February 2025

Romvimza (vimseltinib); Deciphera Pharmaceuticals LLC; To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity, Approved February 2025

Blujepa (gepotidacin); GlaxoSmithKline LLC; To treat uncomplicated urinary tract infections, Approved March 2025

Qfitlia (fitusiran); Genzyme Corp; To prevent or reduce the frequency of bleeding episodes in hemophilia A or B, Approved March 2025

Vanrafia (atrasentan); Novartis Pharmaceuticals Corp; To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression, Approved April 2025

penpulimab-kcqx (penpulimab-kcqx); Akeso Biopharma Co., Ltd.; In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy, Approved April 2025

Imaavy (nipocalimab-aahu); Janssen Biotech, Inc.; To treat generalized myasthenia gravis, Approved April 2025

Avmapki Fakzynja Co-Pack (avutometinib and defactinib); Verastem Inc; To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy, Approved May 2025

Emrelis (telisotuzumab vedotin-tllv); AbbVie Inc.; To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy, Approved May 2025

Tryptyr (acoltremon); Alcon Laboratories Inc; To treat the signs and symptoms of dry eye disease, Approved May 2025

Enflonsia (clesrovimab-cfor); Merck Sharp & Dohme LLC; To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season, Approved June 2025

Ibtrozi (taletrectinib); Nuvation Bio Inc; To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer, Approved June 2025

Andembry (garadacimab-gxii); CSL Behring LLC; To prevent attacks of hereditary angioedema, Approved June 2025

Lynozyfic (linvoseltamab-gcpt); Regeneron Pharmaceuticals, Inc.; To 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 antibody, Approved July 2025

Zegfrovy (sunvozertinib); Dizal (Jiangsu) Pharmaceutical Co Ltd; To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with disease progression on or after platinum-based chemotherapy, Approved July 2025

Ekterly (sebetralstat); KalVista Pharmaceuticals Ltd; To treat acute attacks of hereditary angioedema, Approved July 2025

Anzupgo (delgocitinib); LEO Pharma AS; To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response, Approved July 2025

Sephience (sepiapterin); PTC Therapeutics Inc; To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet, Approved July 2025

Vizz (aceclidine); LENZ Therapeutics Inc; To treat presbyopia, Approved July 2025

Modeyso (dordaviprone); Chimerix Inc; To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy, Approved August 2025

Hernexeos (zongertinib); Boehringer Ingelheim Pharmaceuticals Inc; To treat adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy, Approved August 2025

Brinsupri (brensocatib); Insmed Inc; To treat non-cystic fibrosis bronchiectasis, Approved August 2025

Dawnzera (donidalorsen); Ionis Pharmaceuticals Inc; To prevent attacks of hereditary angioedema, Approved August 2025

Wayrilz (rilzabrutinib); Genzyme Corp; To treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids, Approved August 2025

Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph); Merck Sharp & Dohme LLC; To treat adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab, Approved September 2025

Forzinity (elamipretide); Stealth Biotherapeutics Inc; To improve muscle strength in patients with Barth syndrome weighing at least 30 kg, Approved September 2025

Inluriyo (imlunestrant); Eli Lilly and Co; To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, Approved September 2025

Palsonify (paltusotine); Crinetics Pharmaceuticals Inc; To treat acromegaly in adults who had an inadequate response to surgery and/or for whom surgery is not an option, Approved September 2025

Rhapsido (remibrutinib); Novartis Pharmaceuticals Corp; To treat chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment, Approved September 2025

Jascayd (nerandomilast); Boehringer Ingelheim Pharmaceuticals Inc; To treat idiopathic pulmonary fibrosis, Approved October 2025

Lynkuet (elinzanetant); Bayer HealthCare Pharmaceuticals Inc; To treat moderate-to-severe vasomotor symptoms due to menopause, Approved October 2025

Kygevvi (doxecitine and doxribtimine); UCB Inc; To treat thymidine kinase 2 deficiency in patients who start to show symptoms when they are 12 years old or younger, Approved November 2025

Komzifti (ziftomenib); Kura Oncology Inc; To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options, Approved November 2025

Redemplo (plozasiran); Arrowhead Pharmaceuticals Inc; To reduce triglycerides in adults with familial chylomicronemia syndrome, Approved November 2025

Hyrnuo (sevabertinib); Bayer HealthCare Pharmaceuticals Inc; To treat locally advanced or metastatic non-squamous non-small cell lung cancer with tumors that have activating HER2 tyrosine kinase domain activating mutations in patients who received a systemic therapy, Approved November 2025

Voyxact (sibeprenlimab-szsi); Otsuka Pharmaceutical Company, Ltd.; To reduce proteinuria in primary immunoglobulin A nephropathy in adults at risk for disease progression, Approved November 2025

Lerochol (lerodalcibep-liga); LIB Therapeutics, Inc.; To reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet and exercise, Approved December 2025

Cardamyst (etripamil); Milestone Pharmaceuticals USA Inc; To treat episodes of paroxysmal supraventricular tachycardia, Approved December 2025

Nuzolvence (zoliflodacin); Entasis Therapeutics Inc; To treat uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae, Approved December 2025

Myqorzo (aficamten); Cytokinetics Inc; To treat symptomatic obstructive hypertrophic cardiomyopathy, Approved December 2025

Exdensur (depemokimab-ulaa); GlaxoSmithKline LLC; To treat severe asthma characterized by an eosinophilic phenotype as an add-on maintenance therapy, Approved December 2025

Yartemlea (narsoplimab-wuug); Omeros Corporation; To treat hematopoietic stem cell transplant-associated thrombotic microangiopathy, Approved December 2025

Nereus (tradipitant); Vanda Pharmaceuticals Inc; To treat vomiting associated with motion, Approved December 2025

Zelsuvmi (berdazimer); LNHC Inc.; To treat molluscum contagiosum, Approved January 2024

Exblifep (cefepime, enmetazobactam); Allecra Therapeutics SAS; To treat complicated urinary tract infections, Approved February 2024

Letybo (letibotulinumtoxinA-wlbg); Hugel Inc.; To temporarily improve the appearance of moderate-to-severe glabellar lines, Approved February 2024

Tevimbra (tislelizumab-jsgr); BeiGene USA, Inc.; To treat unresectable or metastatic esophageal squamous cell carcinoma, Approved March 2024

Rezdiffra (resmetirom); Madrigal Pharmaceuticals, Inc.; To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring, Approved March 2024

Tryvio (aprocitentan); Idorsia Pharmaceuticals Ltd; To treat hypertension, Approved March 2024

Duvyzat (givinostat); Italfarmaco S.p.A.; To treat Duchenne muscular dystrophy in individuals aged 6 years and older, Approved March 2024

Winrevair (sotatercept-csrk); Merck Sharp & Dohme LLC; To treat pulmonary arterial hypertension, Approved March 2024

Vafseo (vadadustat); Akebia Therapeutics, Inc.; To treat anemia due to chronic kidney disease, Approved March 2024

Voydeya (danicopan); Alexion Pharmaceuticals, Inc.; To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria, Approved March 2024

Zevtera (ceftobiprole medocaril sodium); Basilea Pharmaceutica International Ltd; To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia, Approved April 2024

Lumisight (pegulicianine); LumiCell, Inc.; To use as an optical imaging agent for the detection of cancerous tissue, Approved April 2024

Anktiva (nogapendekin alfa inbakicept-pmln); Altor Bioscience, LLC; To treat bladder cancer, Approved April 2024

Ojemda (tovorafenib); Day One Biopharmaceuticals, Inc.; To treat relapsed or refractory pediatric low-grade glioma, Approved April 2024

Xolremdi (mavorixafor); X4 Pharmaceuticals, Inc.; To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis), Approved April 2024

Imdelltra (tarlatamab-dlle); Amgen Inc.; To treat extensive stage small cell lung cancer, Approved May 2024

Rytelo (imetelstat); Geron Corp.; To treat low- to intermediate-1 risk myelodysplastic syndromes, Approved June 2024

Iqirvo (elafibranor); Ipsen Biopharmaceuticals, Inc.; To treat primary biliary cholangitis in combination with ursodeoxycholic acid, Approved June 2024

Sofdra (sofpironium); Botanix SB Inc.; To treat primary axillary hyperhidrosis, Approved June 2024

Piasky (crovalimab-akkz); Genentech, Inc.; To treat paroxysmal nocturnal hemoglobinuria, Approved June 2024

Ohtuvayre (ensifentrine); Verona Pharma Inc.; To treat chronic obstructive pulmonary disease, Approved June 2024

Kisunla (donanemab-azbt); Eli Lilly and Company; To treat Alzheimer’s disease, Approved July 2024

Leqselvi (deuruxolitinib); Sun Pharmaceutical Industries, Inc.; To treat severe alopecia areata, Approved July 2024

Voranigo (vorasidenib); Servier Pharmaceuticals LLC; To treat Grade 2 astrocytoma or oligodendroglioma, Approved August 2024

Yorvipath (palopegteriparatide); Ascendis Pharma Bone Diseases A/S; To treat hypoparathyroidism, Approved August 2024

Nemluvio (nemolizumab-ilto); Galderma Laboratories, L.P.; To treat prurigo nodularis, Approved August 2024

Livdelzi (seladelpar); Gilead Sciences, Inc.; To treat primary biliary cholangitis (PBC), Approved August 2024

Niktimvo (axatilimab-csfr); Incyte Corporation; To treat chronic graft-versus-host disease (cGVHD), Approved August 2024

Lazcluze (lazertinib); Janssen Biotech, Inc.; To treat non-small cell lung cancer, Approved August 2024

Ebglyss (lebrikizumab-lbkz); Eli Lilly and Company; To treat moderate-to-severe atopic dermatitis, Approved September 2024

Miplyffa (arimoclomol); Zevra Denmark A/S; To treat Niemann-Pick disease type C, Approved September 2024

Aqneursa (levacetylleucine); IntraBio Inc.; To treat Niemann-Pick disease type C, Approved September 2024

Cobenfy (xanomeline and trospium chloride); Bristol-Myers Squibb Company; To treat schizophrenia, Approved September 2024

Flyrcado (flurpiridaz F 18); GE HealthCare Inc.; A radioactive diagnostic drug to evaluate for myocardial ischemia and infarction, Approved September 2024

Itovebi (inavolisib); Genentech, Inc.; To treat locally advanced or metastatic breast cancer, Approved October 2024

Hympavzi (marstacimab-hncq); Pfizer Inc.; To prevent or reduce bleeding episodes related to hemophilia A or B, Approved October 2024

Vyloy (zolbetuximab-clzb); Astellas Pharma US, Inc.; To treat gastric or gastroesophageal junction adenocarcinoma, Approved October 2024

Orlynvah (sulopenem etzadroxil, probenecid); Iterum Therapeutics US Ltd; To treat uncomplicated urinary tract infections (uUTI), Approved October 2024

Revuforj (revumenib); Syndax Pharmaceuticals, Inc.; To treat relapsed or refractory acute leukemia, Approved November 2024

Ziihera (zanidatamab-hrii); Jazz Pharmaceuticals Ireland Limited; To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, Approved November 2024

Attruby (acoramidis); BridgeBio Pharma, Inc.; To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis, Approved November 2024

Rapiblyk (landiolol); AOP Orphan Pharmaceuticals AG; To treat supraventricular tachycardia, Approved November 2024

Iomervu (iomeprol); Bracco Diagnostics Inc.; For use as a radiographic contrast agent, Approved November 2024

Bizengri (zenocutuzumab-zbco); Merus N.V.; To treat non-small cell lung cancer and pancreatic adenocarcinoma, Approved December 2024

Unloxcyt (cosibelimab-ipdl); Checkpoint Therapeutics, Inc.; To treat cutaneous squamous cell carcinoma, Approved December 2024

Crenessity (crinecerfont); Neurocrine Biosciences, Inc.; To treat classic congenital adrenal hyperplasia, Approved December 2024

Ensacove (ensartinib); Xcovery Holdings, Inc.; To treat non-small cell lung cancer, Approved December 2024

Tryngolza (olezarsen); Ionis Pharmaceuticals, Inc.; To treat familial chylomicronemia syndrome, Approved December 2024

Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor); Vertex Pharmaceuticals Inc.; For the treatment of cystic fibrosis (CF) in patients 6 years of age and older, Approved December 2024

Alhemo (concizumab-mtci); Novo Nordisk Inc.; For routine prophylaxis to prevent bleeding episodes in hemophilia A and B, Approved December 2024

Brenzavvy (bexagliflozin); TheracosBio, LLC; To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise, Approved January 2023

Columvi (glofitamab-gxbm); Genentech, Inc.; To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy, Approved June 2023

Daybue (trofinetide); Acadia Pharmaceuticals Inc.; To treat Rett syndrome, Approved March 2023

Elfabrio (pegunigalsidase alfa-iwxj); Chiesi USA, Inc.; To treat confirmed Fabry disease, Approved May 2023

Epkinly (epcoritamab-bysp); Genmab US, Inc. and AbbVie Inc.; To 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 therapy, Approved May 2023

Filspari (sparsentan); Travere Therapeutics, Inc.; To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression, Approved February 2023

Inpefa (sotagliflozin); Lexicon Pharmaceuticals, Inc.; To treat heart failure, Approved May 2023

Jaypirca (pirtobrutinib); Lilly USA, LLC; To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor, Approved January 2023

Jesduvroq (daprodustat); GlaxoSmithKline; To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months, Approved February 2023

Joenja (leniolisib); Pharming Technologies B.V.; To treat activated phosphoinositide 3-kinase delta syndrome, Approved March 2023

Lamzede (velmanase alfa-tycv); Chiesi USA, Inc.; To treat non-central nervous system manifestations of alpha-mannosidosis, Approved February 2023

Leqembi (lecanemab-irmb); Eisai Inc.; To treat Alzheimer’s disease, Approved January 2023

Miebo (perfluorhexyloctane); Bausch & Lomb Americas Inc.; To treat signs and symptoms of dry eye disease, Approved May 2023

Orserdu (elacestrant); Stemline Therapeutics, Inc.; To 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, Approved January 2023

Paxlovid (nirmatrelvir, ritonavir); Pfizer Inc.; To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19, Approved May 2023

Posluma (flotufolastat F 18); Blue Earth Diagnostics Ltd.; To use with positron emission tomography imaging in certain patients with prostate cancer, Approved May 2023

Qalsody (tofersen); Biogen MA Inc.; To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation, Approved April 2023

Rezzayo (rezafungin); Melinta Therapeutics LLC; To treat candidemia and invasive candidiasis, Approved March 2023

Skyclarys (omaveloxolone); Reata Pharmaceuticals, Inc.; To treat Friedreich’s ataxia, Approved February 2023

Veozah (fezolinetant); Astellas Pharma US, Inc.; To treat moderate to severe hot flashes caused by menopause, Approved May 2023

Xacduro (sulbactam, durlobactam); La Jolla Pharmaceutical Company; To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex, Approved May 2023

Zavzpret (zavegepant); Pfizer Inc.; To treat migraine, Approved March 2023

Zynyz (retifanlimab-dlwr); Incyte Corporation; To treat metastatic or recurrent locally advanced Merkel cell carcinoma, Approved March 2023

Litfulo (ritlecitinib); Pfizer Inc.; To treat severely patchy hair loss, Approved June 2023.

Rystiggo (rozanolixizumab-noli); UCB, Inc.; To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive, Approved June 2023.

Ngenla (somatrogon-ghla); Pfizer Ireland Pharmaceuticals; To treat growth failure due to inadequate secretion of endogenous growth hormone, Approved June 2023.

Beyfortus (nirsevimab-alip); AstraZeneca AB; To prevent respiratory syncytial virus (RSV) lower respiratory tract disease, Approved July 2023.

Vanflyta (quizartinib); Daiichi Sankyo Inc.; To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria, Approved July 2023.

Xdemvy (lotilaner); Tarsus Pharmaceuticals Inc.; To treat Demodex blepharitis, Approved July 2023.

Zurzuvae (zuranolone); Sage Therapeutics Inc.; To treat postpartum depression, Approved August 2023.

Izervay (avacincaptad pegol); Iveric Bio Inc.; To treat geographic atrophy secondary to age-related macular degeneration, Approved August 2023.

Talvey (talquetamab-tgvs); Janssen Biotech, Inc.; To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, Approved August 2023.

Elrexfio (elranatamab-bcmm); Pfizer Inc.; To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, Approved August 2023.

Sohonos (palovarotene); Ipsen Biopharmaceuticals Inc.; To 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 progressiva, Approved August 2023.

Veopoz (pozelimab-bbfg); Regeneron Pharmaceuticals, Inc.; To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease, Approved August 2023.

Aphexda (motixafortide); BioLineRx Ltd.; To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma, Approved September 2023.

Ojjaara (momelotinib); GlaxoSmithKline LLC; To treat intermediate or high-risk myelofibrosis in adults with anemia, Approved September 2023.

Exxua (gepirone); Fabre-Kramer Pharmaceuticals, Inc.; To treat major depressive disorder, Approved September 2023.

Pombiliti (cipaglucosidase alfa-atga); Amicus Therapeutics US, LLC; To treat late-onset Pompe disease, Approved September 2023.

Rivfloza (nedosiran); Novo Nordisk Inc.; To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function, Approved September 2023.

Velsipity (etrasimod); Pfizer Inc.; To treat moderately to severely active ulcerative colitis in adults, Approved October 2023.

Zilbrysq (zilucoplan); UCB Inc.; To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive, Approved October 2023.

Bimzelx (bimekizumab); UCB, Inc.; To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, Approved October 2023.

Agamree (vamorolone); Catalyst Pharmaceuticals Inc.; To treat Duchenne muscular dystrophy, Approved October 2023.

Omvoh (mirikizumab-mrkz); Eli Lilly and Company; To treat ulcerative colitis, Approved October 2023.

Loqtorzi (toripalimab-tpzi); Coherus BioSciences, Inc.; To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies, Approved October 2023.

Fruzaqla (fruquintinib); Takeda Pharmaceuticals USA, Inc.; To treat refractory, metastatic colorectal cancer, Approved November 2023.

Defencath (taurolidine, heparin); CorMedix Inc.; To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter, Approved November 2023.

Augtyro (repotrectinib); Bristol Myers Squibb Co.; To treat ROS1-positive non-small cell lung cancer, Approved November 2023.

Ryzneuta (efbemalenograstim alfa-vuxw); Evive Biotechnology Singapore Pte. Ltd.; To treat neutropenia, Approved November 2023.

Truqap (capivasertib); AstraZeneca Pharmaceuticals LP; To treat breast cancer that meets certain disease criteria, Approved November 2023.

Ogsiveo (nirogacestat); SpringWorks Therapeutics, Inc.; To treat adults with progressing desmoid tumors who require systemic treatment, Approved November 2023.

Fabhalta (iptacopan); Novartis Pharmaceuticals Corp.; To treat paroxysmal nocturnal hemoglobinuria, Approved December 2023.

Filsuvez (birch triterpenes); Chiesi Farmaceutici S.p.A.; To treat wounds associated with dystrophic and junctional epidermolysis bullosa, Approved December 2023.

Wainua (eplontersen); AstraZeneca AB; To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis, Approved December 2023.