FDA actions in brief as reported February 1, 2002
FDA Approves Dupixent for Inflammatory Skin Disease
Chronic spontaneous urticaria is chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch.
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FDA Sets Action Date for Eylea HD in Retinal Vein Occlusion
If approved, Eylea would be the first treatment for RVO with 8-week dosing. The FDA target action date is Aug. 19, 2025.
Novo Nordisk Warns about More Counterfeit Ozempic
The FDA has seized several hundred units of counterfeit Ozempic 1 mg
Liver Injury Ends Development of Pfizer’s Oral GLP-1 for Obesity
In one study, once-daily danuglipron resulted in one patient who experienced drug-related elevated liver enzymes.
FDA Approves Biocon’s Avastin Biosimilar
Jobevne is the fifth Avastin biosimilar, which are recombinant humanized monoclonal antibodies used to treat several different types of cancer.
Payers Consider Policy Options for Access to GLP-1 Obesity Medications
A new paper by the Institute for Clinical and Economic Review (ICER) looks at the cost-effectiveness versus affordability issue of obesity medications such as Wegovy and Zepbound.
