Directory of Novel FDA Approvals, 2024

Orlynvah (sulopenem etzadroxil, probenecid; Iterum Therapeutics)
Class/route: Novel oral penem antibiotic
Indication: To treat uncomplicated urinary tract infections
Approval date: October 25, 2024¹

Vyloy (zolbetuximab-clzb; Astellas)
Class/route: Use in combination with fluoropyrimidine- and platinum-containing chemotherapy
Indication: To treat gastric or gastroesophageal junction cancer
Approval date: October 18, 2024²

Hympavzi (marstacimab-hncq; Pfizer)
Class/route: Prefilled autoinjector pen
Indication: To prevent or reduce bleeding episodes related to hemophilia A or B
Approval date: October 11, 2024³

Itovebi (inavolisib; Genentech)
Class/route: Tablet
Indication: To treat locally advanced or metastatic cancer
Approval date: October 10, 2024⁴

Flyrcado (flurpiridaz F 18; GE Healthcare)
Class/route: Diagnostic agent
Indication: To diagnose and evaluate for myocardial ischemia and infarction
Approval date: September 27, 2024⁵

Cobenfy (xanomeline and trospium chloride; Bristol Myers Squibb)
Class/route: Musarinic agonist
Indication: To treat schizophrenia
Approval date: September 26, 2024⁶

Aqneursa (levacetylleucine; IntraBio Inc)
Class/route: Granules
Indication: To treat Niemann-Pick disease type C
Approval date: September 24, 2024⁷

Miplyffa (arimoclomol, Zefra Therapeutics)
Class/route: Capsule
Indication: To treat Niemann-Pick disease type C
Approval date: September 20, 2024⁸

Ebglyss (lebrikizumab-lbkz; Eli Lilly)
Class/route: Interleukin-13 antagonist/subcutaneous injection
Indication: To treat moderate-to-severe atopic dermatitis
Approval date: September 13, 2024⁹

Lazcluze (lazertinib; Janssen Biotech, Inc)
Class/route: EGFR inhibitor/oral
Indication: To treat non–small cell lung cancer
Approval date: August 19, 2024¹⁰

Niktimvo (axatilimab-csfr; Incyte Corporation and Syndax Pharmaceuticals)
Class/route: CSF-1R-blocking antibody/intravenous infusion
Indication: To treat chronic graft-versus-host disease
Approval date: August 14, 2024¹¹

Livdelzi (seladelpar; Gilead)
Class/route: PPAR-delta agonist/oral
Indication: To treat primary biliary cholangitis
Approval date: August 14, 2024¹²

Nemluvio (nemolizumab-ilto; Galderma Laboratories)
Class/route: Interleukin-31 receptor antagonist/subcutaneous injection
Indication: To treat prurigo nodularis
Approval date: August 12, 2024¹³

Yorvipath (palopegteriparatide; Ascendis Pharma)
Class/route: Parathyroid hormone analog/subcutaneous injection
Indication: To treat hypoparathyroidism
Approval date: August 9, 2024¹⁴

Voranigo (vorasidenib; Servier)
Class/route: Oral
Indication: Grade 2 astrocytoma or oligodendroglioma
Approval date: August 6, 2024¹⁵

Leqselvi (deuruxolitinib; Sun)
Class/route: JAK inhibitor/oral
Indication: To treat severe alopecia areata
Approval date: July 25, 2024¹⁶

Kisunla (donanemab-azbt; Eli Lilly)
Class/route: Amyloid beta-directed antibody/intravenous
Indication: To treat Alzheimer’s disease
Approval date: July 2, 2024¹⁷

Ohtuvayre (ensifentrine; Verona Pharma)
Class/route: PDE3/4/inhalation
Indication: To treat chronic obstructive pulmonary disease
Approval date: June 26, 2024¹⁸

Piasky (crovalimab-akkz; Genentech)
Class/route: Complement C5 inhibitor/intravenous
Indication: To treat paroxysmal nocturnal hemoglobinuria
Approval date: June 20, 2024¹⁹

Sofdra (sofpironium; Botanix Pharmaceuticals Limited)
Class/route: Anticholinergic/topical
Indication: To treat primary axillary hyperhidrosis
Approval date: June 18, 2024²⁰

Iqirvo (elafibranor; Ipsen)
Class/route: PFAR/oral
Indication: To treat primary biliary cholangitis in combination with ursodeoxycholic acid
Approval date: June 10, 2024²¹

Rytelo (imetelstat; Geron Corp)
Class/route: Telomerase inhibitor/intravenous
Indication: To treat low- to intermediate-1 risk myelodysplastic syndromes
Approval date: June 6, 2024²²

Imdelltra (tarlatamab-dlle; Amgen)
Class/route: DLL3-targeting BiTE therapy intravenous
Indication: To treat extensive-stage small cell lung cancer
Approval date: May 16, 2024²³

Xolremdi (mavorixafor; X4)
Class/route: CXCR4/oral
Indication: To treat WHIM syndrome (warts, hypogammaglobulinemia, infections, and myelokathexis)
Approval date: April 26, 2024²⁴

Ojemda (tovorafenib; Day One Biopharmaceuticals)
Class/route: Type 2 RAF inhibitor/oral
Indication: To treat relapsed or refractory pediatric low-grade glioma
Approval date: April 23, 2024²⁵

Anktiva (nogapendekin alfa inbakicept-pmln; Altor Bioscience)
Class/route: IL-15 receptor agonist/intravenous
Indication: Bladder cancer
Approval date: April 22, 2024²⁶

Lumisight (pegulicianine; Lumicell)
Class/route: Imaging tool
Indication: To use as an optical imaging agent for detecting cancerous tissue
Approval date: April 17, 2024²⁷

Zevtera (ceftobiprole medocaril sodium; Basilea Pharmaceutica International)
Class/route: Injection
Indication: To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia
Approval date: April 3, 2024²⁸

Voydeya (danicopan; Alexion)
Class/route: Complement factor D inhibitor/oral
Indication: To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria
Approval date: March 29, 2024²⁹

Vafseo (vadadustat; Akelba Therapeutics)
Class/route: HIF-PH inhibitor/oral
Indication: To treat anemia due to chronic kidney disease
Approval date: March 27, 2024³⁰

Winrevair (sotatercept-csrk; Merck)
Class/route: Activin signaling inhibitor/subcutaneous injection
Indication: To treat pulmonary arterial hypertension
Approval date: March 26, 2024³¹

Duvyzat (givinostat; ITF Therapeutics)
Class/route: HDAC inhibitor/oral
Indication: To treat Duchenne muscular dystrophy in individuals aged ≥6 years
Approval date: March 21, 2024³²

Tryvio (aprocitentan; Idorsia)
Class/route: Endothelin receptor antagonist/oral
Indication: To treat hypertension
Approval date: March 19, 2024³³

Rezdiffra (resmetirom; Madrigal Pharmaceuticals)
Class/route: Thyroid hormone receptor-beta agonist/oral
Indication: To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring
Approval date: March 14, 2024³⁴

Tevimbra (tislelizumab-jsgr; BeiGene)
Class/route: Checkpoint inhibitor/intravenous
Indication: To treat unresectable or metastatic esophageal squamous cell carcinoma
Approval date: March 13, 2024³⁵

Letybo (letibotulinumtoxinA-wlbg; Hugel Inc)
Class/route: Intramuscular
Indication: To temporarily improve the appearance of moderate to severe glabellar lines (brow furrows) in adults
Approval date: February 29, 2024³⁶

Exblifep (cefepime; enmetazobactam, Allecra)
Class/route: Intravenous
Indication: To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms
Approval date: February 2, 2024³⁷

Zelsuvmi (berdazimer; Ligand Pharmaceuticals)
Class/route: Topical
Indication: Treatment of molluscum contagiosum
Approval date: January 5, 2024³⁸

References

1. Iterum Therapeutics. Iterum Therapeutics receives US FDA approval of Orlynvah™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections [press release]. Published October 25, 2024. Accessed November 4, 2024. www.iterumtx.com/news/press-releases/detail/136/iterum-therapeutics-receives-u-s-fda-approval-of#xd_co_f=ZjhjNDUwM2MtZDE3Mi00MTMxLTkwZWItOGRjYWFkZjI5ZjA0~
2. Astellas. Astellas’ Vyloy™ (zolbetuximab-clzb) approved by US FDA for treatment of advanced gastric and GEJ cancer [press release]. Published October 18, 2024. Accessed November 4, 2024. www.prnewswire.com/news-releases/astellas-vyloy-zolbetuximab-clzb-approved-by-us-fda-for-treatment-of-advanced-gastric-and-gej-cancer-302280716.html
3. Pfizer. US FDA approves Pfizer’s Hympavzi™ (marstacimab-hncq) for the treatment of adults and adolescents with hemophilia A or B without inhibitors [press release]. Published October 11, 2024. Accessed November 4, 2024. www.businesswire.com/news/home/20241009505480/en/U.S.-FDA-Approves-Pfizer%E2%80%99s-HYMPAVZI%E2%84%A2-marstacimab-hncq-for-the-Treatment-of-Adults-and-Adolescents-with-Hemophilia-A-or-B-Without-Inhibitors
4. Genentech. FDA approves Genentech’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation [press release]. Published October 10, 2024. Accessed November 4, 2024. www.businesswire.com/news/home/20241008295168/en/FDA-Approves-Genentech%E2%80%99s-Itovebi-a-Targeted-Treatment-for-Advanced-Hormone-Receptor-Positive-HER2-Negative-Breast-Cancer-With-a-PIK3CA-Mutation
5. FDA. FDA approves imaging drug for evaluation of myocardial ischemia and infarction [press release]. Published September 27, 2024. Accessed November 4, 2024. www.fda.gov/drugs/news-events-human-drugs/fda-approves-imaging-drug-evaluation-myocardial-ischemia-and-infarction
6. Bristol Myers Squibb. US Food and Drug Administration approves Bristol Myers Squibb’s Cobenfy™ (xanomeline and trospium chloride), a first-in-class muscarinic agonist for the treatment of schizophrenia in adults [press release]. September 27, 2024. Accessed November 4, 2024. www.businesswire.com/news/home/20240925382351/en/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibb%E2%80%99s-COBENFY%E2%84%A2-xanomeline-and-trospium-chloride-a-First-In-Class-Muscarinic-Agonist-for-the-Treatment-of-Schizophrenia-in-Adults
7. IntraBio Inc. IntraBio announces US FDA approval of Aqneursa for the treatment of Niemann-Pick disease type C [press release]. Published September 25, 2024. Accessed November 4, 2024. www.businesswire.com/news/home/20240925347296/en/IntraBio-Announces-U.S.-FDA-Approval-of-AQNEURSA-for-the-Treatment-of-Niemann-Pick-Disease-Type-C
8. FDA. FDA approves first treatment for Niemann-Pick disease, type C [press release]. September 20, 2024. Accessed November 4, 2024. www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-niemann-pick-disease-type-c
9. Lilly. FDA approves Lilly’s EBGLYSS™ (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis [press release]. September 13, 2024. Accessed September 20, 2024. investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and#:~:text=INDIANAPOLIS%20%2C%20Sept.%2013%2C%202024,88%20pounds%20(40%20kg)%20with
10. FDA. FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer [press release]. August 19, 2024. Accessed September 20, 2024. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-amivantamab-vmjw-non-small-lung-cancer
11. FDA. FDA approves of axatilimab-csfr for chronic graft-versus-host disease [press release]. August 14, 2024. Accessed September 20, 2024. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axatilimab-csfr-chronic-graft-versus-host-disease
12. Gilead. Gilead’s Livdelzi (Seladelpar) granted accelerated approval for primary biliary cholangitis by U.S. FDA. August 14, 2024. Accessed August 14, 2024. www.gilead.com/news-and-press/press-room/press-releases/2024/8/gileads-livdelzi-seladelpar-granted-accelerated-approval-for-primary-biliary-cholngitis-by-us-fda
13. Galderma. Galderma receives US FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis. Published August 13, 2024. Accessed September 20, 2024. www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo
14. Ascendis Pharma. FDA approves Yorvipath (palopegteriparatide) as the first and only treatment for hypoparathyroidism in adults [press release]. August 12, 2024. Accessed September 20, 2024. https://investors.ascendispharma.com/news-releases/news-release-details/fda-approves-yorvipathr-palopegteriparatide-first-and-only
15. FDA. FDA approves vorasidenib for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation [press release]. August 6, 2024. Accessed October 14, 2024. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma-susceptible-idh1-or-idh2-mutation
16. Sun Pharmaceutical Industries. U.S. FDA approves LEQSELVI™ (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata [press release]. July 26, 2024. Accessed July 26, 2024. www.prnewswire.com/news-releases/us-fda--approves-leqselvi-deuruxolitinib-an-oral-jak-inhibitor-for-the-treatment-of-severe-alopecia-areata-302207222.html?tc=eml_cleartime
17. Eli Lilly and Company. FDA approval of Kisunla (donanemab-azbt) [press release]. July 2, 2024. Accessed September 20, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early?utm_source=li&utm_medium=organic&utm_campaign=alz_donli&utm_id=alz
18. Verona Pharma. FDA approval of Ohtuvayre (ensifentrine) [press release]. June 26, 2024. Accessed September 20, 2024. www.veronapharma.com/news/verona-pharma-announces-us-fda-approval-of-ohtuvayre-ensifentrine/
19. Genentech, Inc. FDA approval of Piasky (crovalimab-akkz) [package insert]. June 20, 2024. Accessed September 20, 2024. www.accessdata.fda.gov/drugsatfda_docs/label/2024/761388s000lbl.pdf
20. Botanix Pharmaceuticals Limited. FDA approval of Sofdra (sofpironium) – the first new drug for primary axillary hyperhidrosis [press release]. June 20, 2024. Accessed September 20, 2024. https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819259-6A1212299
21. Ipsen. Ipsen’s Iqirvo receives FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis [press release]. June 10, 2024. Accessed September 20, 2024 www.ipsen.com/press-releases/ipsens-iqirvo-receives-u-s-fda-accelerated-approval-as-a-first-in-class-ppar-treatment-for-primary-biliary-cholangitis/
22. Geron Corporation. Geron announces FDA approval of RYTELO™ (imetelstat), a first-in-class telomerase inhibitor, for the treatment of adult patients with lower-risk MDS with transfusion-dependent anemia [press release]. June 6, 2024. Accessed September 20, 2024. https://ir.geron.com/investors/press-releases/press-release-details/2024/Geron-Announces-FDA-Approval-of-RYTELO-imetelstat-a-First-in-Class-Telomerase-Inhibitor-for-the-Treatment-of-Adult-Patients-with-Lower-Risk-MDS-with-Transfusion-Dependent-Anemia/default.aspx
23. Amgen Inc. FDA approves ImDelltra, the first and only t-cell engager therapy for the treatment of extensive-stage small cell lung cancer [press release]. May 16, 2024. Accessed September 20, 2024. www.amgen.com/newsroom/press-releases/2024/05/fda-approves-imdelltra-tarlatamabdlle-the-first-and-only-tcell-engager-therapy-for-the-treatment-of-extensivestage-small-cell-lung-cancer
24. X4 Pharmaceuticals. X4 Pharmaceuticals announces FDA approval of XOLREMDI™ (mavorixafor) capsules, first drug indicated in patients with WHIM syndrome [press release]. April 26, 2024. Accessed September 20, 2024. https://investors.x4pharma.com/news-releases/news-release-details/x4-pharmaceuticals-announces-fda-approval-xolremditm-mavorixafor
25. Day One Biopharmaceuticals, Inc. Day One’s Ojemda (tovorafenib) receives US FDA accelerated approval for relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG), the most common form of childhood brain tumor [press release]. April 23, 2024. Accessed September 20, 2024. https://ir.dayonebio.com/news-releases/news-release-details/day-ones-ojemdatm-tovorafenib-receives-us-fda-accelerated
26. Altor BioScience, LLC (a subsidiary of ImmunityBio, Inc.). ImmunityBio announces FDA approval of ANKTIVA^®, first-in-class IL-15 receptor agonist for BCG-unresponsive non-muscle invasive bladder cancer [press release]. April 22, 2024. Accessed September 20, 2024. https://immunitybio.com/immunitybio-announces-fda-approval-of-anktiva-first-in-class-il-15-receptor-agonist-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer/
27. FDA. FDA approves imaging drug to assist in detection of cancerous tissue following lumpectomy. April 17, 2024. Accessed October 14, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-imaging-drug-assist-detection-cancerous-tissue-following-lumpectomy
28. FDA. FDA approves new antibiotic for three different uses. April 3, 2024. Accessed October 14, 2024. www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses
29. AstraZeneca. Voydeya approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular haemolysis in adults with the rare disease PNH [press release]. April 1, 2024. Accessed September 20, 2024. www.astrazeneca.com/media-centre/press-releases/2024/voydeya-approved-in-us.html
30. Akebia Therapeutics, Inc. Akebia receives FDA approval of Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease in adult patients on dialysis [press release]. March 27, 2024. Accessed September 20, 2024. https://prnmedia.prnewswire.com/news-releases/akebia-receives-fda-approval-of-vafseo-vadadustat-tablets-for-the-treatment-of-anemia-due-to-chronic-kidney-disease-in-adult-patients-on-dialysis-302101854.html
31. Merck & Co., Inc. FDA approves Merck’s Winrevair (sotatercept-csrk), a first-in-class treatment for adults with pulmonary arterial hypertension (PAH, WHO*Group 1) [press release]. March 26, 2024. Accessed September 20, 2024. www.merck.com/news/fda-approves-mercks-winrevair-sotatercept-csrk-a-first-in-class-treatment-for-adults-with-pulmonary-arterial-hypertension-pah-who-group-1/
32. ITF Therapeutics LLC (a subsidiary of Italfarmaco). FDA approves nonsteroidal treatment for Duchenne muscular dystrophy [press release]. FDA. March 21, 2024. Accessed September 20, 2024. www.fda.gov/news-events/press-announcements/fda-approves-nonsteroidal-treatment-duchenne-muscular-dystrophy
33. Idorsia Pharmaceuticals. US FDA approves Idorsia’s once-daily TRYVIO (aprocitentan) – the first and only endothelin receptor antagonist for the treatment of high blood pressure not adequately controlled in combination with other antihypertensives [press release]. March 20, 2024. Accessed September 20, 2024. https://ml-eu.globenewswire.com/Resource/Download/17ffadbf-f3bf-4f88-8aa6-6046dc84b499
34. Madrigal Pharmaceuticals. Rezdiffra (resmetirom) [package insert]. March 14, 2024. Accessed September 20, 2024. www.madrigalpharma.com/wp-content/uploads/2024/03/Patient-Prescribing-Information.pdf
35. BeiGene, Ltd. BeiGene receives FDA approval for Tevimbra for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy [press release]. March 14, 2024. Accessed September 14, 2024. https://ir.beigene.com/news/beigene-receives-fda-approval-for-tevimbra-for-the-treatment-of-advanced-or-metastatic-esophageal-squamous/20eb032c-15ce-456a-a852-39c88a28d811/
36. Hugel, Inc. March 4, 2024. Accessed November 5, 2024. Hugel receives FDA approval in the United States of Letybo (letibotulinumtoxinA-wlbg) for injection for the treatment of glabellar lines. www.prnewswire.com/news-releases/hugel-receives-fda-approval-in-the-united-states-of-letybo-letibotulinumtoxina-wlbg-for-injection-for-the-treatment-of-glabellar-lines-302078434.html
37. Allecra Therapeutics. Exblifep. [package insert.] Accessed February 27, 2024. Accessed November 5, 2024. www.accessdata.fda.gov/drugsatfda_docs/label/2024/216165s000lbl.pdf.
38. Ligand Pharmaceuticals. Zelsuvmi (berdazimer) [package insert]. January 5, 2024. Accessed September 20, 2024. https://zelsuvmi.com/wp-content/uploads/2024/01/ZELSUVMI-Berdazimer-Topical-Gel-10.3.-Prescribing-Information-and-Instructions-for-Use.pdf.

EDITOR’S NOTE: This listing and references are current as of November 4, 2024. They were generated partially using artificial intelligence assistance.