The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after the drug application has been accepted by the Agency. For drugs that have Priority Review, the review period is reduced to 6 months from the time of application acceptance.
Tabelecleucel for EBV+ Post-Transplant Lymphoproliferative Disease
PDUFA date: January 10, 2026
The FDA is expected to decide on the BLA for tabelecleucel, an allogeneic, Epstein-Barr virus (EBV)-specific T-cell immunotherapy. The application seeks approval for the treatment of adult and pediatric patients 2 years of age and older with EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least 1 prior therapy.
EBV+ PTLD is a rare, acute, and potentially deadly hematologic malignancy that can occur after solid organ or hematopoietic cell transplantation. The BLA was accepted for Priority Review based on data from the pivotal phase 3 ALLELE study (ClinicalTrials.gov Identifier: NCT03394365), which assessed tabelecleucel for EBV+ PTLD in the setting of solid organ transplant after failure of rituximab and rituximab plus chemotherapy, or hematopoietic stem cell transplant after failure of rituximab. Findings showed an objective response rate of 48.8% (P <.0001).
If approved, tabelecleucel would be the first allogeneic T-cell therapy available in the US for this indication.
Sparsentan for Focal Segmental Glomerulosclerosis
PDUFA date: January 23, 2026
The FDA is reviewing the supplemental NDA for sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS). Sparsentan is an oral endothelin and angiotensin II receptor antagonist.
The drug was previously approved to slow kidney function decline in adults with primary immunoglobulin A nephropathy who are at risk for disease progression. The FSGS application is supported by data from the phase 3 DUPLEX study (ClinicalTrials.gov Identifier: NCT03493685) and the phase 2 DUET study (ClinicalTrials.gov Identifier: NCT01613118). Findings showed treatment with sparsentan significantly reduced proteinuria compared with irbesartan in children and adults with FSGS.
The FDA’s approval would make sparsentan the first treatment for this rare kidney disease, which is a leading cause of end-stage renal disease.
PDUFA date: January 23, 2026
The FDA has granted Priority Review to the supplemental BLA for fam-trastuzumab deruxtecan-nxki (Enhertu®) in combination with pertuzumab (Perjeta®) for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
Trastuzumab deruxtecan is a HER2-directed antibody and topoisomerase inhibitor conjugate currently approved as a second-line therapy for HER2-positive metastatic breast cancer. The application for first-line treatment is based on results from the phase 3 DESTINY-Breast09 trial (ClinicalTrials.gov Identifier: NCT04784715).
Findings showed the combination of trastuzumab deruxtecan and pertuzumab significantly improved progression free survival (PFS) compared with the standard-of-care regimen (taxane, trastuzumab, and pertuzumab). The median PFS was 40.7 months for the trastuzumab deruxtecan plus pertuzumab arm vs 26.9 months for the control arm. The confirmed objective response rate was 85.1% vs 78.6%, respectively.
Carbachol/Brimonidine Eyedrop for Presbyopia
PDUFA date: January 28, 2026
The FDA is reviewing the NDA for Brimochol PF, a preservative-free fixed-dose combination of carbachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist) for the treatment of presbyopia.
The application is supported by results from the phase 3 BRIO-I (ClinicalTrials.gov Identifier: NCT05270863) and BRIO-II (ClinicalTrials.gov Identifier: NCT05135286) clinical trials, which evaluated the safety and efficacy of Brimochol PF in patients aged 45 to 80 years with emmetropic phakic and/or pseudophakic presbyopia.
Findings showed the combination therapy significantly improved near and distance binocular visual acuity vs carbachol and brimonidine monotherapies. Significant reductions in pupil size were seen for up to 10 hours with Brimochol PF, in addition to improvements in ocular hyperemia, reading speed, and quality of life.
Epinephrine Sublingual Film for Severe Allergic Reactions
PDUFA date: January 31, 2026
The NDA for Anaphylm, a sublingual film formulation of epinephrine, is under review for the treatment of Type 1 allergic reactions, including anaphylaxis.
Anaphylm is a polymer matrix-based film designed to dissolve rapidly and deliver epinephrine systemically. If approved, it would be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, offering a needle-free alternative.
The NDA submission is supported by a comprehensive clinical data package that includes a pharmacokinetics (PK) study in healthy adults, a pediatric PK study, and supportive data from a temperature study, a self-administration study, and an allergen study. In the Oral Allergy Syndrome challenge study, treatment with Anaphylm resulted in rapid resolution of symptoms beginning 2 minutes after administration.
This article originally appeared on MPR