Abnormality of triglyceride values was most severe in patients during treatment compared with baseline measures.
FDA Approves Monjuvi, Rituximab and Lenalidomide Combination for Relapsed or Refractory Follicular Lymphoma
This is the first FDA-approved CD19- and CD20-targeted immunotherapy combination for adult patients with follicular lymphoma (FL) and the second indication for Monjuvi.
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FDA Approves Hereditary Angioedema Therapy, Andembry
CSL Behring’s Andembry is now approved as a subcutaneous, self-injection for hereditary angioedema (HAE) patients ages 12 and older and will be available by the end of June 2025.
NDA Resubmitted for Investigational Dry Eye Therapy, Reproxalap
Aldeyra has resubmitted its new drug application for reproxalap, an investigational dry eye treatment, which contained new data from an additional FDA-requested trial.
Sandoz Launches Biosimilars of Xgeva/Prolia
Wyost and Jubbonti are interchangeable with Xgeva/Prolia and are approved for all of the same indications in bone cancer and osteoporosis.
Sarepta Stops Shipments of Elevidys For Non-Ambulatory DMD Patients
A second patient with Duchenne muscular dystrophy has died from acute liver failure after receiving the gene therapy Elevidys.
Biosimilar Uptake Has Been Slow but This is Changing
In an interview, James D. Chambers, Ph.D., from Tufts Medical Center, talks about the factors that are impacting the biosimilar market.