Several FDA decisions across multiple specialties are expected this month.

Upcoming July 2026 Prescription Drug User Fee Act dates include regulatory decisions for therapies and products targeting liver imaging in patients with severe kidney impairment, hematologic malignancies, immunoglobulin A nephropathy, advanced breast cancer, hepatocellular carcinoma, multiple myeloma, attention-deficit/hyperactivity disorder, edema associated with chronic heart failure or chronic kidney disease, contraception, and Cushing's syndrome.

Radiology

Orviglance

Ascelia Pharma announced a Prescription Drug User Fee Act (PDUFA) target action date of July 3, 2026, for Ascelia Pharma's New Drug Application (NDA) for Orviglance for use during contrast-enhanced liver magnetic resonance imaging in patients with severe kidney impairment. The NDA is supported by nine clinical studies. According to Ascelia Pharma, Orviglance met the primary endpoint in the phase 3 SPARKLE trial by improving visualization of focal liver lesions in patients with impaired kidney function.

Source: Ascelia Pharma

Oncology

Orca-T

Orca Bio announced a PDUFA target action date of July 6, 2026, for the Biologics License Application (BLA) for its investigational cell therapy Orca-T. Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated for the treatment of hematologic malignancies, including acute leukemias and myelodysplastic syndromes. The therapy received Regenerative Medicine Advanced Therapy and Orphan Drug designations from the US Food and Drug Administration (FDA) for the prevention of graft-versus-host disease or death in patients eligible for hematopoietic stem cell transplant.

Source: Orca Bio

Gedatolisib

Celcuity announced a PDUFA target action date of July 17, 2026, for Celcuity's NDA for gedatolisib in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA wild-type advanced breast cancer. Gedatolisib is an investigational inhibitor of the phosphoinositide 3-kinase/AKT/mammalian target of rapamycin pathway. The NDA is supported by results from the PIK3CA wild-type cohort of the phase 3 VIKTORIA-1 trial.

Source: Celcuity

Rivoceranib Plus Camrelizumab

Elevar Therapeutics announced a PDUFA target action date of July 23, 2026, for its resubmitted NDA for rivoceranib in combination with camrelizumab as first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma. Rivoceranib is an investigational oral vascular endothelial growth factor receptor tyrosine kinase inhibitor administered with camrelizumab, an anti-programmed death-1 antibody. According to Elevar Therapeutics, the application is based on findings from the phase 3 CARES-310 trial.

Source: Elevar Therapeutics

Sarclisa Subcutaneous

Sanofi announced a revised PDUFA target action date of July 23, 2026, for its BLA for the subcutaneous formulation of Sarclisa (isatuximab-irfc) in combination with approved standard-of-care regimens for multiple myeloma across all currently approved US indications for the intravenous formulation. If approved, the subcutaneous formulation would be administered using an on-body injector.

Source: Sanofi

Nephrology

Atacicept

Vera Therapeutics announced a PDUFA target action date of July 7, 2026, for its BLA seeking accelerated approval of atacicept in patients with immunoglobulin A nephropathy. Atacicept is an investigational soluble recombinant fusion protein that binds B-cell activating factor and A PRoliferation-Inducing Ligand. According to the company, the ORIGIN phase 3 trial met its primary endpoint with reduced proteinuria at week 36 in a prespecified interim analysis. Vera also reported that, across the ORIGIN program in immunoglobulin A nephropathy, the safety profile of atacicept appeared comparable to placebo.

Source: Vera Therapeutics

Psychiatry

Centanafadine

Otsuka announced a PDUFA target action date of July 24, 2026, for its review of centanafadine for the treatment of attention-deficit/hyperactivity disorder in children, adolescents, and adults. Centanafadine is an investigational once-daily norepinephrine, dopamine, and serotonin reuptake inhibitor. According to Otsuka, a phase 3b study of adults with attention-deficit/hyperactivity disorder and comorbid anxiety found that centanafadine improved attention-deficit/hyperactivity disorder symptoms compared with placebo.

Source: Otsuka

Cardiology

FUROSCIX ReadyFlow Autoinjector

MannKind announced that the FDA accepted for review its supplemental NDA for the FUROSCIX ReadyFlow Autoinjector, an investigational alternative delivery system for the approved FUROSCIX on-body infusor, with a PDUFA target action date of July 26, 2026. The application seeks approval of the autoinjector for the treatment of edema in adults with chronic heart failure or chronic kidney disease. The device is designed to deliver subcutaneous furosemide in less than 10 seconds. According to MannKind, the application is supported by results from an open-label, randomized crossover study of 21 healthy volunteers in which the autoinjector demonstrated bioavailability comparable to intravenous furosemide and produced similar urine output and urinary sodium and potassium excretion at 6, 8, and 12 hours. MannKind reported that treatment was generally well tolerated with respect to injection-site pain.

Source: MannKind

ObGyn

Low-Dose Estrogen Combined Hormonal Weekly Patch

Viatris announced that the FDA accepted for review its NDA for an investigational low-dose estrogen combined hormonal contraceptive weekly patch, with a PDUFA target action date of July 30, 2026. The once-weekly transdermal patch is being developed as a reversible contraceptive option for women of childbearing potential with a body mass index below 30 kg/m² who are appropriate candidates for combined hormonal contraception. According to Viatris, the application is supported by results from a multicenter, open-label, single-arm phase 3 study evaluating contraceptive efficacy, safety, and patch adhesion performance.

Source: Viatris, Inc

Looking Ahead: 

Endocrinology

Relacorilant

Corcept Therapeutics has resubmitted its NDA to the FDA for relacorilant for the treatment of patients with Cushing's syndrome. Relacorilant is an oral glucocorticoid receptor antagonist that modulates cortisol activity. According to Corcept Therapeutics, the resubmission is supported by data from the pivotal GRACE trial, the phase 3 GRADIENT trial, a long-term extension study, and earlier-stage development data.

Source: Corcept Therapeutics