2024 FDA Approvals

Here at PharmaTell, we had Eyes on FDA Approvals for 2024. Below, we share the 50 Novel Drug Approvals and 17 Biologic License Application Approvals for 2024, as provided on the FDA website. Many of the companies/products are covered in the PharmaTell Database. If you want more details, search the company catalog and add the product name for research specifically on that therapy. We will be tracking the monthly approvals in 2025, so check back regularly.

2024 Novel Drug Approvals

No.	Drug Name	Active Ingredient	Approval Date	FDA-approved use on approval date*
50.	Alhemo	concizumab-mtci	12/20/2024	For routine prophylaxis to prevent bleeding episodes in hemophilia A and B. Novo Nordisk
49.	Alyftrek	vanzacaftor, tezacaftor, and deutivacaftor	12/20/2024	To treat cystic fibrosis. Vertex
48.	Tryngolza	olezarsen	12/19/2024	To treat familial chylomicronemia syndrome. Ionis
47.	Ensacove	ensartinib	12/18/2024	To treat non-small cell lung cancer. Xcovery Holdings
46.	Crenessity	crinecerfont	12/13/2024	To treat classic congenital adrenal hyperplasia. Neurocrine Biosciences  Press Release
45.	Unloxcyt	cosibelimab-ipdl	12/13/2024	To treat cutaneous squamous cell carcinoma. Checkpoint Therapeutics
44.	Bizengri	zenocutuzumab-zbco	12/4/2024	To treat non-small cell lung cancer and pancreatic adenocarcinoma. Merus NV
43.	Iomervu	iomeprol	11/27/2024	For use as a radiographic contrast agent. Bracco Diagnostic
42.	Rapiblyk	landiolol	11/22/2024	To treat supraventricular tachycardia. AOP Orphan Pharmaceuticals
41.	Attruby	acoramidis	11/22/2024	To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis. BridgeBio
40.	Ziihera	zanidatamab-hrii	11/20/2024	To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. Jazz Pharma
39.	Revuforj	revumenib	11/15/2024	To treat relapsed or refractory acute leukemia. Zyndax Pharma
38.	Orlynvah	sulopenem etzadroxil, probenecid	10/25/2024	To treat uncomplicated urinary tract infections (uUTI). Iterum Therapeutics
37.	Vyloy	zolbetuximab-clzb	10/18/2024	To treat gastric or gastroesophageal junction adenocarcinoma. Astellas Pharma  Drug Trials Snapshots: VYLOY
36.	Hympavzi	marstacimab-hncq	10/11/2024	To prevent or reduce bleeding episodes related to hemophilia A or B. Pfizer  Press ReleaseDrug Trials Snapshot
35.	Itovebi	inavolisib	10/10/2024	To treat locally advanced or metastatic breast cancer. Genentech
34.	Flyrcado	flurpiridaz F 18	9/27/2024	A radioactive diagnostic drug to evaluate for myocardial ischemia and infarction. GE Healthcare
33.	Cobenfy	xanomeline and trospium chloride	9/26/2024	To treat schizophrenia.  BMS  Press Release
32.	Aqneursa	levacetylleucine	9/24/2024	To treat Niemann-Pick disease type C. IntraBio LTD  Press ReleaseDrug Trials Snapshot
31.	Miplyffa	arimoclomol	9/20/2024	To treat Niemann-Pick disease type C. Zevra Therapeutics  Press Release Drug Trials Snapshot
30.	Ebglyss	lebrikizumab-lbkz	9/13/2024	To treat moderate-to-severe atopic dermatitis. Lilly  Drug Trials Snapshot
29.	Lazcluze	lazertinib	8/19/2024	To treat non-small cell lung cancer. Janssen Biotech  Drug Trials Snapshot
28.	Niktimvo	axatilimab-csfr	8/14/2024	To treat chronic graft-versus-host disease (cGVHD). Incyte  Drug Trials Snapshot
27.	Livdelzi	seladelpar	8/14/2024	To treat primary biliary cholangitis (PBC). Cyma Bay TheraputicsDrug Trials Snapshot
26.	Nemluvio	nemolizumab-ilto	8/12/2024	To treat prurigo nodularis. Galderma  Drug Trials Snapshot
25.	Yorvipath	palopegteriparatide	8/9/2024	To treat hypoparathyroidism. Ascendis Pharma  Drug Trials Snapshot
24.	Voranigo	vorasidenib	8/6/2024	To treat Grade 2 astrocytoma or oligodendroglioma. Servier Pharma  Drug Trials Snapshot
23.	Leqselvi	deuruxolitinib	7/25/2024	To treat severe alopecia areata. Sun Pharma  Drug Trials Snapshot
22.	Kisunla	donanemab-azbt	7/2/2024	To treat Alzheimer’s disease. Lilly  Drug Trials Snapshot
21.	Ohtuvayre	ensifentrine	6/26/2024	To treat chronic obstructive pulmonary disease. Verona Pharma  Drug Trials Snapshot
20.	Piasky	crovalimab-akkz	6/20/2024	To treat paroxysmal nocturnal hemoglobinuria. Genentech  Drug Trials Snapshot
19.	Sofdra	sofpironium	6/18/2024	To treat primary axillary hyperhidrosis. Botanix  Drug Trials Snapshot
18.	Iqirvo	elafibranor	6/10/2024	To treat primary biliary cholangitis in combination with ursodeoxycholic acid. Ipsen BioPharma  Drug Trials Snapshot
17.	Rytelo	imetelstat	6/6/2024	To treat low- to intermediate-1 risk myelodysplastic syndromes. Geron Corp  Drug Trials Snapshot
16.	Imdelltra	tarlatamab-dlle	5/16/2024	To treat extensive stage small cell lung cancer. Amgen  Drug Trials Snapshot
15.	Xolremdi	mavorixafor	4/26/2024	To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis). X4 Pharma  Drug Trials Snapshot
14.	Ojemda	tovorafenib	4/23/2024	To treat relapsed or refractory pediatric low-grade glioma. Day One BioPharma  Drug Trials Snapshot
13.	Anktiva	nogapendekin alfa inbakicept-pmln	4/22/2024	To treat bladder cancer. Altor Bioscience  Drug Trials Snapshot
12.	Lumisight	pegulicianine	4/17/2024	To use as an optical imaging agent for the detection of cancerous tissue. Lumicell  Drug Trials Snapshot
11.	Zevtera	ceftobiprole medocaril sodium	4/3/2024	To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia. Basilea Pharma  Press ReleaseDrug Trials Snapshot
10.	Voydeya	danicopan	3/29/2024	To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria. Alexion  Drug Trials Snapshot
9.	Vafseo	vadadustat	3/27/2024	To treat anemia due to chronic kidney disease. Akebia Therapeutics  Drug Trials Snapshot
8.	Winrevair	sotatercept-csrk	3/26/2024	To treat pulmonary arterial hypertension. Merck & Co  Drug Trials Snapshot
7.	Duvyzat	givinostat	3/21/2024	To treat Duchenne muscular dystrophy in individuals aged 6 years and older. Italfarmaco Group  Press ReleaseDrug Trials Snapshot
6.	Tryvio	aprocitentan	3/19/2024	To treat hypertension. Idorsia Pharmaceuticals  Drug Trials Snapshot
5.	Rezdiffra	resmetirom	3/14/2024	To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring. Madrigal Pharma  Press ReleaseDrug Trials Snapshot
4.	Tevimbra	tislelizumab-jsgr	3/13/2024	To treat unresectable or metastatic esophageal squamous cell carcinoma. BeiGene  Drug Trials Snapshot
3.	Letybo	letibotulinumtoxinA-wlbg	2/29/2024	To temporarily improve the appearance of moderate-to-severe glabellar lines. Hugel  Drug Trials Snapshot
2.	Exblifep	cefepime, enmetazobactam	2/22/2024	To treat complicated urinary tract infections. Allector Therap  Drug Trials Snapshot
1.	Zelsuvmi	berdazimer	1/5/2024	To treat molluscum contagiosum. Ligand  Drug Trials Snapshot

 Source: FDA Website - Novel Drug Approvals here, PharmaTell Addition of Company Names.

  2024 Biologic License Application Approvals 

Tradename/ Proper Name	Indication for Use	STN	Manufacturer/License Number	Approval Date
Kebilidi eladocagene exuparvovec-tneq	For treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency.	125722/0	PTC Therapeutics, Inc.500 Warren Corporate Center DriveWarren, New Jersey 07059Lic. # 2168	11/13/2024
Aucatzyl  obecabtagene autoleucel	Indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).	125813/0	Autolus Inc.15810 Gaither Drive, Suite 230Gaithersburg, MD 20877Lic. # 2339	11/08/2024
TECELRA afamitresgene autoleucel	Indicated for treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.	125789/0	Adaptimmune LLC351 Rouse BoulevardPhiladelphia, PA 19112Lic. # 2315	08/01/2024
CAPVAXIVE Pneumococcal 21-valent Conjugate Vaccine	Indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.	125814/0	Merck Sharp & Dohme LLCP.O. Box 1000 UG2D-68North Wales, PA 19454-2505Lic. # 0002	06/17/2024
YIMMUGO immune globulin intravenous, human-dira	Indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age or older.	125810/0	Biotest AGLandsteinerstrasse 5Dreieich, Hesse63303GermanyLic. # 2332	06/13/2024
MRESVIA Respiratory Syncytial Virus Vaccine	Indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.	125796/0	ModernaTX, Inc.325 Binney StreetCambridge, MA02142Lic. # 2256	05/31/2024
BEQVEZ elaparvovec-dzkt	Indicated for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who: currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and, do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test.	125786/0	Pfizer, Inc.445 Eastern Point RoadGroton, CT 06340Lic. # 2001	04/25/2024
cobas Malaria cobas Malaria, Nucleic Acid Test for use on the cobas 6800/8800 Systems	Is a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium (P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. It is also intended for use in testing whole blood samples to screen organ and tissue donors when samples are obtained while the donor’s heart is still beating.	125808/0	Roche Molecular Systems, Inc.4300 HaciendaDrivePleasanton, CA94588-2722Lic. # 1636	03/19/2024
LENMELDY atidarsagene autotemcel	Indicated for treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD).	125758/0	OrchardTherapeutics(Europe) LimitedOrchardTherapeuticsNorth America101 SeaportBoulevard, 7thFloorBoston, MA 02210Lic. # 2263	03/18/2024
Elecsys Anti-HCV II Elecsys Anti-HCV II	An in vitro immunoassay for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma. It is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens.	125803/0	Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250Lic. # 2305	02/28/2024
Elecsys Anti-HBc II Elecsys Anti-HBc II	An in vitro immunoassay for the qualitative detection of antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma. It is intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.	125804/0	Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250Lic. # 2305	02/27/2024
Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm  Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm	An in vitro immunoassay intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma. It is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.	125802/0	Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250Lic. # 2305	02/21/2024
AMTAGVI Lifileucel	Indicated for treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.	125773/0	Iovance Biotherapeutics, Inc.825 Industrial Road, Suite 400San Carlos, CA 94070Lic. # 2298	02/16/2024
Elecsys Chagas Elecsys Chagas	An in vitro immunoassay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi, the causative agent of the Chagas disease) in human serum and plasma. It’s intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.	125799/0	Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250Lic. # 2305	02/05/2024
Source Plasma	Indicated for further manufacturing of injectable products.	125783/0	Life Plasma, Inc.5438 Perkiomen AvenueReading, PA 19606Lic. # 2311	01/30/2024
Source Plasma	Indicated for further manufacturing of injectable products.	125783/0	Life Plasma, Inc.5438 Perkiomen AvenueReading, PA 19606Lic. # 2311	01/30/2024
CASGEVY Exagamglogene autotemcel	Indicated the treatment of patients aged 12 years and older with transfusion-dependent ß-thalassemia (TDT).	125785/0	Vertex Pharmaceuticals Inc50 Northern AvenueBoston, MA 02210Lic. # 2279	01/16/2024

Source: FDA Website - Biologic License Application approvals here.  

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