Heading into 2025, the chief item on argenx’s agenda is the FDA’s April 10 target action date to decide on the approval of a ...

Penmenvy combines the antigenic components of Bexsero (meningococcal Group B vaccine) and Menveo (meningococcal Groups A, C, Y, and W-135 oligosaccharide diphtheria CRM197 conjugate vaccine).

So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval ...

The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent ...

Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis and multiple myeloma/bone metastases from solid tumors.

Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe ...