This quarterly review on New Drug Applications contain data for applications approved during the first quarter of 2026, which includes New Molecular Entities (NMEs) and new biologics. A total of 28applications were approved by FDA during these three months.
The NDAs approved during the first quarter of 2026 have been divided into eight different dosage forms. Following are the percentages of those dosage forms – Injection (53.6%), Tablets (10.7%), Capsules (7.1%), Oral solution (10.7%), Gas (7.1%), and other (3.6% each, topical ointment, tablet for oral suspension, and ophthalmic solution). Recently, there has been more focus on injectable formulations. Following are the submission classifications: BLA (20.0%), Type 1 (New Molecular Entity, 23.3%), Type 3 (New Dosage Form, 20.0%), Type 4 (New Combination, 6.7%), Type 5 (New Formulation or Manufacturer, 23.3%) and Gas/Air – 6.7%
Menkes disease is caused by mutations in genes coding for the copper-transport protein ATP7A leading to copper deficiency. It causes growth failure and nervous system deterioration in children. Zycubo contains copper histidinate. This is the first and only treatment for Menkes disease.
Yuvezzi (Brimonidine and Carbachol) has been approved to treat presbyopia in adults. Presbyopia is a physiological insufficiency of optimal accommodation associated with aging of eyes. It has two actives – carbachol and brimonidine. Carbochol helps pupils to get smaller (constrict), making it easier to focus up close. Brimonidine helps keep pupils from getting too large (dilate).
Arginase 1 is an enzyme found mainly in the liver and it plays a role in various biological processes. Loargys (Pegzilarginase-NBLN) is the first enzyme replacement therapy for Arginase – 1 deficiency. Arginase -1 is involved in the urea cycle. This cycle detoxifies ammonia, a highly toxic product of protein and amino acid breakdown.
Lynavoy (Linerixibat) is the first oral IBAT inhibitor for treating cholestatic pruritus in adults with primary biliary cholangitis. IBAT (ileal bile acid transport) inhibitors are used to treat pruritic. IBAT reduce the levels of bile acids in circulation.
|
Approval
Date
|
Drug
name
|
Active
ingredients
|
Submission
class. *
|
Dosage
form
|
Company
|
Comments
|
|---|
|
01/12/2026
|
Zycubo
|
Copper
histidinate
|
Type 1
|
Sentynl Therapeutics, Inc.
|
Powder;
Subcutaneous
|
First and only FDA-approved treatment for Menkes disease in pediatric patients
|
|
01/15/2026
|
Filkri
|
Filgrastim-
laha
|
BLA
|
Accord Biopharma Inc.
|
Injectable;
Injection
|
FDA-approved biosimilar to Neupogen (filgrastim)
|
|
01/21/2026
|
Avtozma
|
Tocilizumab-
Anoh
|
BLA
|
Celltrion Inc.
|
Injectable;
IV infusion;
Subcutaneous
|
First biological treatment approved for psoriatic arthritis in adults
|
|
01/26/2026
|
Quiofic
|
Folic acid
|
Type 3
|
CMP Development LLC
|
Solution; Oral
|
Used to treat megaloblastic anemias caused by folic acid deficiency
|
|
01/28/2026
|
Yuvezzi
|
Brimonidine
tartrate;
carbachol
|
Type 3 and Type 4
|
Visus
|
Solution
Ophthalmic
|
For the treatment of presbyopia in adults
|
|
02/02/2026
|
Air
|
Air
|
Air
|
General Air Service &
Supply Company
|
Gas; Inhalation
|
Respiratory therapy
|
|
02/03/2026
|
Vykoura
|
Leucovorin
calcium
|
Type 5
|
Avyxa Holdings
|
Solution; IM, IV
|
Folate analog injectable medication used in cancer treatment
|
|
02/12/2026
|
Adquey
|
Difamilast
|
Type 1
|
Acrotech
Biopharma
|
Ointment;
Topical
|
Nonsteroidal topical ointment to treat atopic dermatitis (eczema)
|
|
02/13/2026
|
Avopef
|
Etoposide
|
Type 3
|
Avyxa Holdings
|
Vial; Multidose
|
Topoisomerase inhibitor used to treat certain types of cancer
|
|
02/13/2026
|
Rybrevant
Faspro
|
Amivantamab and Hyaluronidase
|
BLA
|
Janssen Biotech
|
Vial; Single-Use
|
Treat advanced non–small cell lung cancer (NSCLC) with certain EGFR mutation
|
|
02/17/2026
|
Medical air, USP
|
Air
|
Air
|
Unknown
|
Gas; Inhalation
|
Used for respiratory support in hospitals
|
|
02/20/2026
|
Favlyxa
|
Fluorouracil
|
Type 5
|
Avyxa Holdings
|
Solution;
Intravenous
|
Reformulated oncology product
|
|
02/20/2026
|
Bysanti
|
Milsaperidone
|
Type 1
|
Vanda Pharma Inc.
|
Tablet; Oral
|
For the treatment of schizophrenia and acute manic/mixed episodes of bipolar I disorder in adults
|
|
Approval
Date
|
Drug
name
|
Active
ingredients
|
Submission class. *
|
Dosage
form
|
Company
|
Comments
|
|---|
|
02/23/2026
|
Loargys
|
Pegzilarginase-
NBLN
|
BLA
|
Immedica Pharma AB
|
Injectable;
Injection
|
The first enzyme replacement therapy for arginase-1 deficiency (hyperargininemia) in patients aged 2 years and older
|
|
02/25/2026
|
Desmoda
|
Desmopressin
acetate
|
Type 3
|
Eton
|
Solution; Oral
|
The first FDA-approved liquid formulation for treating central diabetes insipidus
|
|
02/27/2026
|
Duloxetine
hydrochloride
|
Duloxetine HCl
|
Type 5
|
Almatica
|
Capsule, DR Pellets; Oral
|
New formulation
|
|
02/27/2026
|
Yuviwel
|
Navepegritide
|
Type 1
|
Ascendis
|
Powder;
Subcutaneous
|
New pediatric rare disease drug (achondroplasia)
|
|
02/27/2026
|
Prezcobix
ped
|
Cobicistat;
darunavir
ethanolate
|
Type 3
|
Janssen
|
Tablet, For Oral Suspension
|
Expanded use to younger pediatric patients
|
|
03/06/2026
|
Pylarify
truvu
|
Piflufolastat f-18
|
Type 5
|
Aphelion
|
Solution;
Intravenous
|
Updated imaging agent
|
|
03/17/2026
|
Icotyde
|
Icotrokinra HCl
|
Type 1
|
Janssen
Biotech
|
Tablet; Oral
|
For moderate-to-severe plaque psoriasis
|
|
03/17/2026
|
Lynavoy
|
Linerixibat
|
Type 1
|
GlaxoSmithKline
|
Tablet; Oral
|
The first oral IBAT inhibitor for treating itching (cholestatic pruritus) in adults with primary biliary cholangitis
|
|
03/19/2026
|
Flavalta
|
Epinephrine bitartrate;
lidocaine HCl
|
Type 5
|
Deproco
|
Solution;
Injection
|
Labeling/manufacturing documentation update
|
|
03/19/2026
|
Kitprozy
|
Carfilzomib
|
Type 5
|
Amneal
Pharma
|
Vial; Single-Use
|
Tentative approval
|
|
03/20/2026
|
Atoncy
|
Atomoxetine HCl
|
Type 3
|
Map77
|
Solution; Oral
|
Reformulated oral solution of atomoxetine for ADHD
|
|
03/24/2026
|
Avlayah
|
Tividenofusp alfa-eknm
|
BLA
|
Denali
Therapeutics
Inc.
|
Injection; Powder, For Solution
|
For the treatment of neurologic manifestations of Hunter syndrome.
|
|
03/25/2026
|
Lifyorli
|
Relacorilant
|
Type 1
|
Corcept
Therapeutics
|
Capsule; Oral
|
It is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA) in oncology use
|
|
03/27/2026
|
Ponlimsi
|
Denosumab-adet
|
BLA
|
Teva
Pharmaceuticals,
Inc.
|
Injectable;
Subcutaneous
|
A biosimilar to Prolia
|
|
03/30/2026
|
Epinephrine
|
Epinephrine
|
Type 4 and Type 5
|
Baxter
Heallthcare
Corp.
|
Solution; IM, IM,
Subcutaneous
|
Updated the label, removed the minimum age requirement
|
|
Type 1 – New Molecular Entity, Type 3 – New Dosage Form, Type 4 - New Combination, Type 5 - New Formulation or New Manufacturer, BLA – Biologics License Application, Subcu – subcutaneous.
|