Immune Disorders

The BX rating indicates that the data are insufficient to show that the product provides the same therapeutic effect as Prograf.

Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody.

Use of the affected product can potentially lead to underdosing or overdosing due to non-uniform distribution of cyclosporine.

Tarpeyo contains 4mg of budesonide, a corticosteroid, in a delayed-release capsule.

The table below is a review of notable updates that occurred in July 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

GC5107B is a liquid solution containing 10% immunoglobulin G for IV infusion, manufactured from pooled human plasma from US donors.

Benefits include maintenance of urine protein creatinine ratio reductions, preserved kidney function.

The table below is a review of notable updates that occurred in June 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

The table below is a review of notable updates that occurred in May 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

May 2023 Notable Drug Approvals

Prevymis is a CMV DNA terminase complex inhibitor.

KYV-101 is a novel, fully human anti-CD19 chimeric antigen receptor T-cell therapy.

Reviewers discussed new and conventional therapies for lupus nephritis and the prospect of precision medicine.

The approval was based on data from the double-blind, placebo-controlled PIONEER trial.

Panel votes unanimously in favor of an over-the-counter change for contraceptive pill; First pharmacological therapy for agitation associated with dementia due to Alzheimer disease; Elfabrio approved for the treatment of Fabry disease; Farxiga approval expanded; Bacterial contamination concerns for certain COVID-19 at-home tests.

There are currently no FDA-approved therapeutics for BKV infection.

CABA-201 is a 4-1BB-containing fully human CD19-CAR T cell therapy.

The 50mL/10gm prefilled syringe is expected to be available in early 2024.

Hyqvia is a subcutaneous immune globulin treatment that can be administered once a month.

March 2023 Notable Drug Approvals