This quarterly review on New Drug Applications contains data for applications approved for the first time during the second quarter of 2026, which includes New Molecular Entities (NMEs) and new biologics. A total of 29 applications were approved by FDA during these three months. Based on submission classification, they can be divided as – Type 1: 32.2%, Type 3: 3.2%, Type 4: 12.9%, Type 5: 19.6%, Type 8: 3.2%, and BLA: 29.0%. Clearly, the focus was on developing New Molecular Entities and new biological products.
The approvals were divided into six different dosage forms. Following are the percentages of those dosage forms – 31.3% tablets, 41.4% injectable, 3.5% each for capsules, metered inhaler and topical gel and 10.3% for powder for injection. All the BLAs were injectable products.
Cipepofol (Chinese trade name: Sishuning) became the first China-originated innovative intravenous anesthetic to enter the global market. This milestone has officially opened the door to the global high-standard pharmaceutical market and secured its entry ticket. The internationalization journey of Cipepofol epitomizes the shift from “Made in China” to “Innovated in China”.
Zaynich is a novel injectable antibiotic developed to treat serious bacterial infections, especially complicated urinary tract infections. It is a combination of two components; cefepime, a fourth-generation cephalosporin antibiotic, and zidebactam, a new molecule developed by Wockhardt. Zaynich is the first fully homegrown Indian antibiotic to receive this recognition, marking a historic achievement for India. By creating Zaynich, Indian scientists have demonstrated that the country can also become a leader in pharmaceutical innovation.
Decnupaz is an antibody-drug conjugate. It works by targeting BPDCN cells that have a protein – CD123 on them. Thus, Decnupaz is a targeted drug delivery for CD-123.
Hepcludex (bulevirtide-gmod) is a prescription medicine used to treat chronic (long-lasting) hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established.
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Approval Date
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Drug Name
|
Active Ingredients
|
Submission Classification *
|
Company
|
Type of Dosage Form/Route
|
Comments
|
|---|
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04/01/2026
|
Foundayo
|
Orforglipron
Calcium
|
Type 1
|
Eli Lilly And Co.
|
Tablet
|
The only GLP-1 pill for weight loss with no food or water restrictions
|
|
04/20/2026
|
Idvynso
|
Doravirine;
Islatravir
|
Type 1, Type 4
|
MSD
|
Tablet
|
First and only non-INSTI, tenofovir-free, once-daily 2-drug regimen for HIV-1
|
|
04/24/2026
|
Saphnelo
|
Anifrolumab-Fnia
|
BLA
|
AstraZeneca
|
Injection
|
For moderate to severe lupus (SLE)
|
|
04/29/2026
|
Langlara
|
Insulin Glargine-Aldy
|
BLA
|
Sunshine Lake Pharma Co. Ltd.
|
Subcutaneous
injection
|
Long-acting insulin analog for diabetes
|
|
05/01/2026
|
Jakafi XR
|
Ruxolitinib
Phosphate
|
Type 5
|
Incyte Corp.
|
Tablet, ER
|
To treat polycythemia
vera (PV)
|
|
05/01/2026
|
Veppanu
|
Vepdegestrant
|
Type 1
|
Rigel Pharma
|
Tablet
|
The first FDA-approved PROTAC protein degrader.
|
|
05/01/2026
|
Evdi
|
Trabectedin
|
Type 5
|
Apotex
|
Injection
Solution
|
For the treatment of metastatic liposarcoma
|
|
05/07/2026
|
Dolutegravi,
Lamivudine
Tenofovir
Disoproxil
Fumarate
|
Dolutegravir;
Lamivudine;
Tenofovir
Disoproxil
Fumarate
|
Type 4
|
Aspen Sa
Operations (Pty) Ltd
|
Tablet; Oral
|
To treat human immunodeficiency virus (HIV) infection
|
|
05/07/2026
|
Ennumo
|
Pegfilgrastim-PCCG
|
BLA
|
Accord
Biopharma
|
Subcutaneous
injection
|
It is a leukocyte growth factor
|
|
05/13/2026
|
Beqalzi
|
Sonrotoclax
|
Type 1
|
Beone
Medicines USA
|
Tablet
|
BCL-2 inhibitor for relapsed or refractory mantle cell lymphoma (MCL)
|
|
05/14/2026
|
Trimbow
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Beclomethasone Dipropionate; Formoterol Fumarate; Glycopyrrolate
|
Type 4
|
Chiesi
|
Aerosol,
Metered;
Inhalation
|
For chronic obstructive pulmonary disease (COPD) and asthma
|
|
05/15/2026
|
Baxfendy
|
Baxdrostat
|
Type 1
|
AstraZeneca
|
Tablet
|
First and only aldosterone synthase inhibitor for adult hypertension
|
|
05/15/2026
|
Immgolis
|
Golimumab-Sldi
|
BLA
|
Accord
Biopharma Inc.
|
Injection;
Solution
|
First interchangeable biosimilars to Simponi/Simponi Aria (golimumab)
|
|
05/15/2026
|
Immgolis
Intri
|
Golimumab-Sldi
|
BLA
|
Accord
Biopharma Inc.
|
Injection
Solution
|
FDA-approved first interchangeable golimumab biosimilars for RA and ulcerative colitis
|
|
05/22/2026
|
Differin E
piduo
|
Adapalene;
Benzoyl Peroxide
|
Type 8
|
Galderma Labs LP
|
Gel; Topical
|
First dual-active clinically proven acne treatment
|
|
05/22/2026
|
Hepcludex
|
Bulevirtide-Gmod
|
BLA
|
Gilead
Sciences Inc.
|
Powder for Injection
|
First and only HDV treatment for adults without cirrhosis or with compensated cirrhosis
|
|
05/27/2026
|
Decnupaz
|
Pivekimab Sunirine-Pvzy
|
BLA
|
AbbVie Inc.
|
Injection
|
The first targeted antibody-drug conjugate with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
|
|
05/29/2026
|
Cavhanza
|
Nilotinib
|
Type 5
|
Flex Pharma
|
Tablet, ODT
|
ODT Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)
|
|
05/29/2026
|
Xocova
|
Ensitrelvir
|
Type 1
|
Shionogi
|
Tablet
|
The first and only oral antiviral approved for post-exposure prophylaxis (PEP) of COVID-19
|
|
05/29/2026
|
Cipepofol
|
Cipepofol
|
Type 1
|
Haisco Pharma
|
Injection
|
The first China-originated innovative intravenous anesthetic to enter the U.S. market
|
|
05/29/2026
|
Zaynich
|
Cefepime HCl;
Zidebactam
|
Type 1, Type 4
|
Wockhardt Bio Ag
|
Powder for Injection
|
First India-discovered and developed new chemical entity FDA-approved for cUTI.
|
|
06/02/2026
|
Tiocystin
|
Tiopronin
|
Type 5
|
Casper Pharma LLC
|
Tablet
|
For prevention of cystine stones in adults and children ≥9 years
|
|
06/02/2026
|
Ranluspec
|
Ranibizumab-Hkdz
|
BLA
|
Lupin Limited
|
Injection
|
For wet age-related macular degeneration and other retinal vascular conditions
|
|
06/12/2026
|
Ambelvist
|
Gadoquatrane
|
Type 1
|
Bayer Healthcare
|
Solution
|
The lowest-dose macrocyclic gadolinium-based contrast agent (mgbca) for MRI
|
|
06/16/2026
|
Aprepitant
|
Aprepitant
|
Type 5
|
Azurity
|
Emulsion;
Injection
|
As a ready-to-use intravenous antiemetic.
|
|
06/17/2026
|
Utebzi
|
Tebipenem
Pivoxil HBr
|
Type 1
|
GlaxoSmithKline
|
Tablet
|
The first and only oral carbapenem antibiotic for adults
|
|
06/24/2026
|
Navitrux
|
Fosaprepitant
Dimeglumine
|
Type 5
|
Avyxa Holdings
|
Powder for
Injection
|
To prevent acute and delayed nausea and vomiting linked to initial and repeat courses of cancer chemotherapy
|
|
06/26/2026
|
Lumvoa
|
Veligrotug-Vvze
|
BLA
|
Viridian
Therapeutics
|
Injection
|
First treatment authorized for thyroid eye disease
|
|
06/29/2026
|
Abanta
|
Apixaban
|
Type 3
|
Azurity
|
Capsule
|
Tentatively approved
|
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, and Type 8 – Prescription to OTC switch