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.
Research highlights expanding diagnostic capabilities but persistent gaps in antiviral therapy and vaccine coverage for pediatric enterovirus infections.
