Eli-cel is an investigational one-time gene therapy designed to add functional copies of the ABCD1 gene into a patient’s own hematopoietic stem cells.
Tlando is supplied as 112.5mg of testosterone undecanoate capsules.
The application included data from the phase 2 BEYOND study.
The EMPRISE study assessed the efficacy and safety of empagliflozin use in approximately 500,000 adults with type 2 diabetes.
The FDA extended the action date by 3 months to allow more time to review additional analyses of data from the Company’s clinical studies.
The study enrolled women who completed the 24-week LIBERTY 1 and 2 studies and the 28-week open-label extension studies, and who met the definition of a responder.
Byooviz (ranibizumab-nuna) is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.