FDA fast tracks drug for metastatic breast cancer

The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.

Chronic spontaneous urticaria is chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch.

If approved, Eylea would be the first treatment for RVO with 8-week dosing. The FDA target action date is Aug. 19, 2025.

The FDA has seized several hundred units of counterfeit Ozempic 1 mg

In one study, once-daily danuglipron resulted in one patient who experienced drug-related elevated liver enzymes.

Jobevne is the fifth Avastin biosimilar, which are recombinant humanized monoclonal antibodies used to treat several different types of cancer.