Original New Drug Application Approvals by US FDA (1-15 September 2026)
12 Oct 2026
New drug applications approved by US FDA as of 1-15 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.
ZANVASTRO
ZANVASTRO
- Active Ingredient(s): Zilganersen Sodium
- Strength: EQ 56MG BASE/2.8ML (EQ 20MG BASE/ML)
- Dosage Form(s) / Route(s): Solution;intrathecal
- Company: Ionis Pharms INC
- Approval Date: 3 September 2026
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of Alexander disease in pediatric and adult patients.
- Approved Label: 3 September 2026 (PDF)
- Active Ingredient(s): Cabozantinib Laurylsulfate
- Strength: EQ 11.5MG BASE; EQ 23MG BASE; EQ 34.5MG BASE
- Dosage Form(s) / Route(s): Capsule;oral
- Company: Handa Oncol
- Approval Date: 3 September 2026
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for the treatment of:
- patients with advanced renal cell carcinoma (RCC).
- patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab.
- patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
- adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
- Approved Label: 3 September 2026 (PDF)
- Active Ingredient(s): Camizestrant
- Strength: 75MG
- Dosage Form(s) / Route(s): Tablet;oral
- Company: Astrazeneca
- Approval Date: 4 September 2026
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated:
- in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
- Approved Label: 4 September 2026 (PDF)
- Active Ingredient(s): Floretyrosine F-18
- Strength: 5-300mCi/ML
- Dosage Form(s) / Route(s): Solution;intravenous
- Company: Telix
- Approval Date: 11 September 2026
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.
- Approved Label: 11 September 2026 (PDF)
- Active Ingredient(s): Apitegromab-mstn
- Strength: 150MG/3ML (50MG/ML)
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Scholar Rock INC
- Approval Date: 11 September 2026
- Submission Classification: NA
- Indication(s): Indicated for the treatment of spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment.
- Approved Label: 11 September 2026 (PDF)
- Active Ingredient(s): Lutetium Lu-177 Dotatate
- Strength: 10mCi/ML
- Dosage Form(s) / Route(s): Solution;intravenous
- Company: Curium
- Approval Date: 14 September 2026
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
- Approved Label: 14 September 2026 (PDF)