SHANGHAI, Sept. 5, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, and Pakistan's The Searle Company Limited (PSX: SEARL, ...
"Today's approval of XGEVA illustrates what is possible when scientific innovation, commitment and investment come together to advance medicine," said Kevin Sharer, chairman and chief executive ...
Shanghai Henlius Biotech and Organon have received permission from the Food and Drug Administration for Bildyos (denosumab-nxxp) injection 60 mg/ml and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 ...
SHANGHAI, Dec. 16, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with an integrated industry chain, announced that it has completed the first commercial shipment of ...
Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA® (denosumab ...
FDA’s boxed warning on denosumab follows study results showing increased and early risks of severe hypocalcemia in patients on dialysis. The Food and Drug Administration (FDA) has added a new boxed ...
Following the positive opinions of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorizations for Teva’s biosimilars PONLIMSI and DEGEVMA ...
(RTTNews) - Biocon Biologics Ltd., a fully integrated global biosimilars company and subsidiary of Biocon Ltd., announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved Bosaya ...
Boncresa is supplied as a 60mg/mL single-dose prefilled syringe for SC injection and Oziltus is supplied as a 120mg/1.7mL single-dose vial for SC injection. Boncresa is approved to treat ...