New drug applications approved by US FDA as of 16-31 August 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.

PASATRU

Active Ingredient(s): Garetosmab-grts
Strength: 300MG/5ML
Dosage Form(s) / Route(s): Injectable;intravenous
Company: Regeneron Pharmaceuticals, INC
Approval Date: 19 August 2026
Submission Classification: NA
Indication(s): Indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).
Approved Label: 19 August 2026 (PDF)

VOBRIG

Active Ingredient(s): Leuprolide Acetate
Strength: 28MG/2.8ML (10MG/ML)
Dosage Form(s) / Route(s): solution;subcutaneous
Company: Sun Pharm
Approval Date: 26 August 2026
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for the treatment of central precocious puberty in pediatric patients.
Approved Label: 26 August 2026 (PDF)

RASONQUE

Active Ingredient(s): Daraxonrasib
Strength: 100MG; 150MG
Dosage Form(s) / Route(s): Tablet;oral
Company: Revolution Medicines
Approval Date: 26 August 2026
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who ace not candidates for multiagent systemic therapy.
Approved Label: 26 August 2026 (PDF)

BIXLENVO

Active Ingredient(s): Bictegravir Sodium; Lenacapavir Sodium
Strength: EQ 75MG BASE; EQ 50MG BASE
Dosage Form(s) / Route(s): Tablet;oral
Company: Gilead Sciences
Approval Date: 27 August 2026
Submission Classification: Type 4 - New Combination
Indication(s): Indicated as a complete regimen for the treatment of HIV-1 in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO.
Approved Label: 27 August 2026 (PDF)

MIMRYLO

Active Ingredient(s): Rusfertide Acetate
Strength: EQ 9.5MG BASE/VIAL, EQ 19MG BASE/VIAL, EQ 28MG BASE/VIAL, EQ 41MG BASE/VIAL, EQ 54MG BASE/VIAL
Dosage Form(s) / Route(s): powder;subcutaneous
Company: Takeda Pharms Am
Approval Date: 28 August 2026
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated d for the treatment of erythrocytosis in adults with polycythemia vera (PV).
Approved Label: 28 August 2026 (PDF)

Original New Drug Application Approvals by US FDA (16-31 August 2026)