This quarterly review of New Drug Applications contains data for applications approved for the first time during the last quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 40 applications were approved by the FDA during these three months. Based on submission classification, they can be divided as – Type 1: 24.4%, Type 2: 4.9%, Type 3: 14.6%, Type 4: 2.4%, Type 5: 9.8%, Type 9: 2.4%, Type 10: 2.4%, Gas: 2.4% and BLA: 36.6%. Clearly, the focus was on developing new biological products.
The last quarter of 2025 approvals were divided into 10 different dosage forms. Following are the percentages of those dosage forms – 20% tablets, 50% injectable, 7.5% each for capsules and oral solutions, and 2.5% each for nasal spray, ophthalmic solution, oral film, gas, oral pellets and oral suspension. All the BLAs except one (Wegovy) were injectable products.
Ferabright™, is the first and only FDA-approved iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. Ferabright is an advanced superparamagnetic iron oxide nanoparticle contrast agent engineered for high relaxivity. It significantly enhances image contrast and precision in brain tumor delineation compared to non-contrast MRI, offering clinicians a new tool for diagnostic imaging and improved patient care.
Cardamyst™ is a prescription medicine used to help restore normal heart rhythm in adults who have symptoms of sudden episodes of fast heartbeat called paroxysmal supraventricular tachycardia (PSVT). It is the first and only self-administered nasal spray for adults with PSVT.
Javadin™ is the only FDA-approved, immediate-release, ready-to-use oral liquid clonidine formulation for hypertension control. It is a central alpha-2 adrenergic agonist, indicated for the treatment of hypertension in adult patients to lower blood pressure. Lowering blood pressure has been shown to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Wegovy (Semaglutide) tablets 25 mg have been introduced by Novo Nordisk, Inc. It is the first and only GLP-1 medication available as a tablet. The pill form of Wegovy is more affordable than the injection and it is more convenient to administer. It mimics GLP-1 hormone to reduce appetite, slow digestion and improve blood sugar regulation.
Yartemlea (Narsoplimab-wuug) is a MASP-2 inhibitor (mannan-binding lectin-associated serine protease 2) indicated for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). It is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody produced in Chinese Hamster Ovary cells. The approximate molecular weight is 143 kDa.
Rybrevant Faspro™ (amivantamab and hyaluronidase-Ipuj) is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and has certain abnormal epidermal growth factor receptor (EGFR) gene(s). Hyaluronidase temporarily breaks down hyaluronan - a major component of the extracellular matrix in subcutaneous tissue - which otherwise creates physical resistance to injecting and absorbing large-volume biologic drugs like monoclonal antibodies.
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Approval
Date
|
Drug Name
|
Active
Ingredients
|
Submission
Classification *
|
Company
|
Type Of Dosage Form/ Route
|
Comments
|
|---|
|
10/02/2025
|
Eydenzelt
|
Aflibercept-Boav
|
BLA
|
Celltrion Inc
|
Injectable;
Injection
|
Treat several serious retinal diseases
|
|
10/07/2025
|
Lasix Onyu
|
Furosemide
|
Type 3
|
Sq Innovation
|
Solution;
Subcutaneous
|
Treatment of edema in adult patients with CHF
|
|
10/07/2025
|
Jascayd
|
Nerandomilast
|
Type 1
|
Boehringer
Ingelheim
|
Tablet; Oral
|
Idiopathic pulmonary fibrosis, progressive pulmonary fibrosis)
|
|
10/16/2025
|
Ferabright
|
Ferumoxytol
|
Type 10
|
Covis
|
Solution;
Intravenous
|
First and only iron-based MRI contrast agent in adults.
|
|
10/17/2025
|
Epioxa Hd/Epioxa Kit
|
Riboflavin 5'-
Phosphate
Sodium
|
Type 5
|
Glaukos
|
Solution/Drops;
Ophthalmic
|
First non-invasive topical drug therapy for corneal collagen cross-linking for keratoconus.
|
|
10/22/2025
|
Contepo
|
Fosfomycin Disodium
|
Type 2
|
Meitheal
|
Powder;
Intravenous
|
Treatment of complicated urinary tract infections (cutis), including acute pyelonephritis.
|
|
10/23/2025
|
Dehydrated
Alcohol
|
Alcohol
|
Type 5
|
Royal Pharma
|
Solution;
Intravenous
|
Treatment of methanol poisoning in combination with hemodialysis
|
|
10/23/2025
|
Javadin
|
Clonidine HCl
|
Type 3
|
Azurity
|
Solution; Oral
|
First ready-to-use oral liquid formulation of clonidine to help lower blood pressure
|
|
10/23/2025
|
Blenrep
|
Belantamab Mafodotin-Blmf
|
BLA
|
Glaxo SmithKline LLC
|
Injectable;
Injection
|
For relapsed or refractory multiple myeloma
|
|
10/24/2025
|
Rocuronium
Bromide
|
Rocuronium
Bromide
|
Type 5
|
B. Braun
Medical
|
Solution;
Intravenous
|
Adjunct to general anesthesia for intubation and muscle relaxation during surgery or mechanical ventilation
|
|
10/24/2025
|
Lynkuet
|
Elinzanetant
|
Type 1
|
Bayer
Healthcare
|
Capsule; Oral
|
To reduce moderate to severe hot flashes associated with menopause.
|
|
10/24/2025
|
Resniben
|
Cabozantinib
|
Type 5
|
Azurity
|
Tablet; Oral
|
Tentative approval
|
|
10/25/2025
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Carbon
Dioxide, USP
|
Carbon Dioxide
|
Gas
|
Roberts Oxygen Co. Inc.
|
Gas; Inhalation
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Designated medical gas
|
|
10/29/2025
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Jubereq
|
Denosumab-
Desu
|
BLA
|
Accord
Biopharma Inc.
|
Injectable;
Subcutaneous
|
Biosimilar to Xgeva® (denosumab)
|
|
10/29/2025
|
Osvyrti
|
Denosumab-
Desu
|
BLA
|
Accord
Biopharma Inc.
|
Injectable;
Subcutaneous
|
Biosimilar to Prolia® (denosumab)
|
|
11/03/2025
|
Kygevvi
|
Doxecitine;
Doxribtimine
|
Type 1
|
UCB Inc.
|
For Solution;
Oral
|
First FDA approved therapy for TK2 deficiency (thymidine kinase 2 deficiency)
|
|
11/13/2025
|
Komzifti
|
Ziftomenib
|
Type 1
|
Kura Oncology
|
Capsule; Oral
|
For a specific type of blood cancer.
|
|
11/13/2025
|
Poherdy
|
Pertuzumab-
Dpzb
|
BLA
|
Shanghai
Henlius Biotech
|
Injectable;
Intravenous
|
Interchangeable to Perjeta
|
|
11/18/2025
|
Redemplo
|
Plozasiran
Sodium
|
Type 1
|
Arrowhead
Pharma
|
Solution;
Subcutaneous
|
Treatment for a rare lipid disorder
|
|
11/19/2025
|
Hyrnuo
|
Sevabertinib
|
Type 1
|
Bayer Healthcare
|
Tablet; Oral
|
Approved under the accelerated approval pathway.
|
|
11/21/2025
|
Ruxolitinib
|
Ruxolitinib
|
Type 2
|
Apotex Inc.
|
Tablet; Oral
|
Cancer growth blocker.
|
|
11/25/2025
|
Voyxact
|
Sibeprenlimab-
Szsi
|
BLA
|
Otsuka Pharma Co.
|
Injectable;
Injection
|
To reduce protein in the urine with a kidney disease.
|
|
Approval
Date
|
Drug Name
|
Active
Ingredients
|
Submission
Classification *
|
Company
|
Type Of Dosage Form/ Route
|
Comments
|
|---|
|
11/28/2025
|
Armlupeg
|
Pegfilgrastim-
Unne
|
BLA
|
Lupin Ltd.
|
Injection;
Solution
|
To reduce the incidence of febrile neutropenia in patients treated with chemotherapy
|
|
12/11/2025
|
Orladeyo
|
Berotralstat 2 HCl
|
Type 3
|
Biocryst
Pharma
|
Pellets; Oral
|
To prevent attacks of hereditary angioedema (HAE) for ages 12 and older
|
|
12/11/2025
|
Daybue
Stix
|
Trofinetide
|
Type 3
|
Acadia Pharma Inc.
|
Solution; Oral
|
The first and only FDA-approved treatment for RETT syndrome.
|
|
12/12/2025
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Cardamyst
|
Etripamil
|
Type 1
|
Milestone Pharma USA
|
Spray; Nasal
|
First and only FDA-approved, self-administered medicine to help restore normal heart rhythm in adults with PSYT.
|
|
12/12/2025
|
Nuzolvence
|
Zoliflodacin
|
Type 1
|
Entasis
Therapeuticcs
|
For Suspension
|
Single-dose oral treatment for urogenital gonorrhea.
|
|
12/12/2025
|
Lerochol
|
Lerodalcibep-
Liga
|
BLA
|
LIB Therapeutics, Inc.
|
Injectable; Injection
|
To reduce low-density lipoprotein cholesterol (LDL-C)
|
|
12/16/2025
|
Vybrique
|
Sildenafil Citrate
|
Type 3
|
IBSA
|
Film; Oral
|
To treat erectile dysfunction (ED).
|
|
12/16/2025
|
Exdensur
|
Depemokimab-
Ulaa
|
BLA
|
GlaxoSmithKline LLC
|
Injection
|
Maintenance treatment for severe asthma, eosinophilic type; the first and only asthma biologic - just 2 doses a year
|
|
12/17/2025
|
Rybrevant
Faspro
|
Amivantamab And Hyaluronidase-Ipuj
|
BLA
|
Janssen
Biotech
|
Injection
|
The first and only subcutaneous therapy for epidermal growth factor receptor-mutated non-small cell lung cancer
|
|
12/18/2025
|
Nufymco
|
Ranibizumab-Leyk
|
BLA
|
Formycon Ag
|
Injection
|
Interchangeable ranibizumab biosimilar, for retinal diseases
|
|
12/19/2025
|
Myqorzo
|
Aficamten
|
Type 1
|
Cytokinetics
|
Tablet; Oral
|
Used to treat adults with symptomatic obstructive cardiomyopathy (OHCM).
|
|
12/19/2025
|
Jascayd
NDA
|
Nerandomilast
|
Type 9
|
Boehringer
Ingelheim
|
Tablet; Oral
|
To treat idiopathic pulmonary fibrosis (IPF) in adult patients.
|
|
12/19/2025
|
Boncresa
|
Denosumab-Mobz
|
BLA
|
Amneal Pharma LLC
|
Injectable;
Subcutaneous
|
To increase bone mass and reduce fracture risk
|
|
12/19/2025
|
Oziltus
BLA
|
Denosumab-Mobz
|
BLA
|
Amneal Pharma LLC
|
Injectable;
Subcutaneous
|
To reduce bone complications, control tumor-related bone disease, and manage cancer-related hypercalcemia.
|
|
12/22/2025
|
Mucinex 12 Hr Cold & Fever
|
Dextromethorphan/
Guaifenesin/
Naproxen
|
Type 4
|
Reckitt
Benckiser
Health
|
Tablet, Extended Release; Oral
|
To loosen phlegm (mucus) and thin bronchial secretions, reduces cough
|
|
12/22/2025
|
Wegovy
|
Semaglutide
|
BLA, Type 3
|
Novo
Nordisk Inc.
|
Tablet
|
The first and only GLP-1 weight-loss medication available in a pill
|
|
12/23/2025
|
Yartemlea
|
Narsoplimab-
Wuug
|
BLA
|
Omeros Corp.
|
Injection
|
The first and only FDA–approved treatment for TA-TMA
|
|
12/30/2025
|
Nereus
|
Tradipitant
|
Type 1
|
Vanda Pharma Inc.
|
Capsule; Oral
|
The first new pharmacologic motion sickness treatment in over 40 years.
|
|
BLA: Biologics License agreement, Type 1: New Molecular entity, Type 2: New active ingredient, Type 3: New dosage form, Type 4 – New combination, Type 5 – New formulation or manufacturer, Type 9 - new indication submitted as distinct NDA, consolidated with original NDA after approval, Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated.
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