Original New Drug Application Approvals by US FDA (1-15 May 2026)

New drug applications approved by US FDA as of 1-15 May 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.

JAKAFI XR

• Active Ingredient(s): Ruxolitinib Phosphate
• Strength: EQ 11MG BASE; EQ 22MG BASE; EQ 33MG BASE; EQ 44MG BASE; EQ 55MG BASE
• Dosage Form(s) / Route(s): Tablet, Extended Release;oral
• Company: Incyte Corp
• Approval Date: 1 May 2026
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for treatment of:
  • intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults.
  • polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
  • steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.
  • chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older
• Approved Label:  1 May 2026 (PDF)

VEPPANU

• Active Ingredient(s): Vepdegestrant
• Strength: 100MG; 200MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Arvinas Operations
• Approval Date: 1 May 2026
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
• Approved Label:  1 May 2026 (PDF)

EVDI

• Active Ingredient(s): Trabectedin
• Strength: 1MG/20ML (0.05MG/ML)
• Dosage Form(s) / Route(s): Solution;intravenous
• Company: Apotex
• Approval Date: 1 May 2026
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.
• Approved Label:  1 May 2026 (PDF)

ENNUMO

• Active Ingredient(s): Pegfilgrastim-pccg
• Strength: 6MG/0.6ML
• Dosage Form(s) / Route(s): Injectable;subcutaneous
• Company: Accord Biopharma INC.
• Approval Date: 7 May 2026
• Submission Classification: NA
• Indication(s): Indicated in adults and pediatric patients aged newborn and older to:
• Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
• Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
• Approved Label:  7 May 2026 (PDF)

BEQALZI

• Active Ingredient(s): Sonrotoclax
• Strength: 1MG; 5MG; 20MG; 80MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Beone Medicines USA
• Approval Date: 13 May 2026
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
  This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
• Approved Label:  13 May 2026 (PDF)

TRIMBOW

• Active Ingredient(s): Beclomethasone Dipropionate; Formoterol Fumarate; Glycopyrrolate
• Strength: 0.086MG/INH;0.0049MG/INH;0.0106MG/INH; 0.172MG/INH;0.0049MG/INH;0.0106MG/INH
• Dosage Form(s) / Route(s): Aerosol, Metered;inhalation
• Company: Chiesi
• Approval Date: 14 May 2026
• Submission Classification: Type 4 - New Combination
• Indication(s): Indicated for the maintenance treatment of asthma in adult patients aged 18 years and older.
  Limitations of Use
  Not indicated for relief of acute bronchospasm.
• Approved Label:  14 May 2026 (PDF)

BAXFENDY

• Active Ingredient(s): Baxdrostat
• Strength: 1MG; 2MG
• Dosage Form(s) / Route(s): Tablet; Oral
• Company: Astrazeneca Pharms
• Approval Date: 15 May 2026
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adults who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
• Approved Label:  15 May 2026 (PDF)

IMMGOLIS

• Active Ingredient(s): Golimumab-sldi
• Strength: 50MG/0.5ML; 100MG/1ML
• Dosage Form(s) / Route(s): Injection;solution
• Company: Accord Biopharma INC.
• Approval Date: 15 May 2026
• Submission Classification: NA
• Indication(s): Indicated for the treatment of:
  • adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
  • adult patients with moderately to severely active ulcerative colitis (UC)
• Approved Label:  15 May 2026 (PDF)

IMMGOLIS INTRI

• Active Ingredient(s): Golimumab-sldi
• Strength: 50MG/4ML
• Dosage Form(s) / Route(s): Injection;solution
• Company: Accord Biopharma INC.
• Approval Date: 15 May 2026
• Submission Classification: NA
• Indication(s): Indicated for the treatment of:
  • adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
  • adult patients with moderately to severely active ulcerative colitis (UC)
• Approved Label:  15 May 2026 (PDF)