Enjaymo is an immunoglobulin G subclass 4 monoclonal antibody.
The approval was based on data from the KEYNOTE-091 trial.
Recent data show that the product is unlikely to be active against currently circulating SARS-CoV-2 variants.
It was originally approved in 2019 for the treatment of chronic pain.
Lisocabtagene maraleucel is a CD19-directed genetically modified autologous T cell immunotherapy.
The CD20-directed cytolytic antibody therapy was approved based on data from two phase 3 trials.
The pembrolizumab combination was not associated with an improvement in overall survival or radiographic progression-free survival.
Rezafungin is an investigational echinocandin antifungal that is administered once weekly.
Odactra is an allergen extract indicated as immunotherapy for the treatment of HDM-induced allergic rhinitis.
The prescription-only device works with integrated continuous glucose monitors and alternate controller enabled pumps.
