Vanrafia reduces proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). It has a wholesale acquisition cost ...

The APPA, if passed into law, puts an upper limit of 20 patents, but only of certain types of patents (see below), that can be asserted in a BPCIA litigation (the APPA does not affect ANDA litigations ...

Organon and Shanghai Henlius Biotech have announced that the European Medicines Agency (EMA) has validated a marketing authorisation application for HLX11, a biosimilar candidate referencing Roche’s ...

On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...

Osvyrti ®– Bone / Osteoporosis (60mg Pre-Filled Syringe) Jubereq ®– Oncology (120mg Vial) Joe Dunford, Accord's Vice ...

Dr. Reddy's inks collaboration deal with Bio-Thera to develop and commercialize proposed biosimilar candidates of J&J's Stelara and Simponi in Southeast Asia.

Alvotech's 427% revenue surge in 2024—fueled by its biosimilar portfolio and global expansion—highlights the booming ...

On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...

The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...