Objective:
To outline FDA decisions for various therapies and products scheduled for July 2026.
Approach:
- Radiology: Orviglance by Ascelia Pharma targets liver imaging in patients with severe kidney impairment, with a PDUFA date of July 3, 2026. The NDA is supported by nine clinical studies.
- Oncology: Orca-T by Orca Bio is an investigational T-cell immunotherapy for hematologic malignancies, with a PDUFA date of July 6, 2026. The therapy received Regenerative Medicine Advanced Therapy and Orphan Drug designations.
- Oncology: Gedatolisib by Celcuity is for advanced breast cancer, with a PDUFA date of July 17, 2026. The NDA is supported by results from the phase 3 VIKTORIA-1 trial.
- Oncology: Rivoceranib plus camrelizumab by Elevar Therapeutics targets hepatocellular carcinoma, with a PDUFA date of July 23, 2026. The application is based on findings from the phase 3 CARES-310 trial.
- Oncology: Sanofi's subcutaneous Sarclisa formulation for multiple myeloma has a revised PDUFA date of July 23, 2026.
- Nephrology: Atacicept by Vera Therapeutics seeks approval for immunoglobulin A nephropathy, with a PDUFA date of July 7, 2026. The ORIGIN phase 3 trial met its primary endpoint.
- Psychiatry: Centanafadine by Otsuka is under review for ADHD, with a PDUFA date of July 24, 2026. A phase 3b study found that centanafadine improved ADHD symptoms compared to placebo.
- Cardiology: MannKind's FUROSCIX ReadyFlow Autoinjector for edema treatment has a PDUFA date of July 26, 2026. The application is supported by results from a study demonstrating bioavailability comparable to intravenous furosemide.
Key Findings:
- Orviglance met primary endpoint in phase 3 SPARKLE trial.
- Orca-T received Regenerative Medicine Advanced Therapy and Orphan Drug designations.
- Gedatolisib's NDA supported by phase 3 VIKTORIA-1 trial results.
- Rivoceranib application based on phase 3 CARES-310 trial findings.
- Atacicept met primary endpoint in ORIGIN phase 3 trial.
- Centanafadine improved ADHD symptoms compared to placebo.
- FUROSCIX autoinjector demonstrated bioavailability comparable to intravenous furosemide.
Interpretation:
The FDA is reviewing multiple therapies across various specialties, with several PDUFA dates set for July 2026.
Conclusion:
The article highlights significant upcoming FDA decisions that may impact treatment options in various medical fields.
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