New drug applications approved by US FDA as of 16-30 September 2026 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

LYRFIGTU

Active Ingredient(s): Lirafugratinib Hydrochloride
Strength: 20MG; 30MG
Dosage Form(s) / Route(s): Capsule; Oral
Company: Elevar Therapeutics INC
Approval Date: 23 September 2026
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring a FGFR2 fusion or other rearrangement.
Approved Label: 23 September 2026 (PDF)

ONSWIK

Active Ingredient(s): Insulin Efsitora Alfa-gobe
Strength: 500 UNITS/ML; 1000 UNITS/ML
Dosage Form(s) / Route(s): Injectable;subcutaneous
Company: Eli Lilly And Co
Approval Date: 23 September 2026
Submission Classification: NA
Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
- Not recommended for use in patients with type 1 diabetes mellitus due to increased risk of severe hypoglycemia
Approved Label: 23 September 2026 (PDF)

ZUEINO

Active Ingredient(s): Diclofenac Sodium
Strength: 37.5MG
Dosage Form(s) / Route(s): Injectable;intravenous
Company: Adventapharma Dwc LLC
Approval Date: 25 September 2026
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for use in adults for the:
- management of mild to moderate pain
- management of moderate to severe pain alone or in combination with opioid analgesics
Approved Label: 25 September 2026 (PDF)

JUVMO

Active Ingredient(s): Tavapadon
Strength: 0.25MG; 1MG; 5MG; 10MG; 15MG
Dosage Form(s) / Route(s): Tablet;oral
Company: Abbvie INC
Approval Date: 25 September 2026
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of Parkinson’s disease in adults.
Approved Label: 25 September 2026 (PDF)

LAMLIQUE

Active Ingredient(s): Lamotrigine Hemifumarate
Strength: EQ 5MG BASE/ML; EQ 25MG BASE/ML
Dosage Form(s) / Route(s): Suspension;oral
Company: Azurity
Approval Date: 25 September 2026
Submission Classification: Type 2 - New Active Ingredient
Indication(s): Indicated for:
Epilepsy—adjunctive therapy in patients aged 2 years and older:
- partial-onset seizures.
- primary generalized tonic-clonic (PGTC) seizures.
- generalized seizures of Lennox-Gastaut syndrome.
Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug.
Bipolar disorder in adults: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in adult patients treated for acute mood episodes with standard therapy.
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of LAMLIQUE in the acute treatment of mood episodes has not been established.
Approved Label: 25 September 2026 (PDF)

ATEBRIOZ

Active Ingredient(s): Zilurgisertib
Strength: 25MG
Dosage Form(s) / Route(s): Tablet; Oral
Company: Incyte Corp
Approval Date: 25 September 2026
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated to reduce the volume of total new heterotopic ossification (HO) in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP).
Approved Label: 25 September 2026 (PDF)

DEGEVMA

Active Ingredient(s): Denosumab-adet
Strength: 120MG/1.7ML (70MG/ML)
Dosage Form(s) / Route(s): Injectable;subcutaneous
Company: Teva Pharmaceuticals, INC.
Approval Date: 25 September 2026
Submission Classification: NA
Indication(s): Indicated for:
- Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
- Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
- Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Approved Label: 25 September 2026 (PDF)

EMCITATE

Active Ingredient(s): Tiratricol
Strength: 350MCG
Dosage Form(s) / Route(s): Tablet; Oral
Company: Rare Thyroid Therapeutics International Ab
Approval Date: 28 September 2026
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-HerndonDudley syndrome).
Limitation of Use
EMCITATE is not recommended for the treatment of primary hypothyroidism.
Approved Label: 28 September 2026 (PDF)

Original New Drug Application Approvals by US FDA (16-30 September 2026)