FairJourney Biologics has acquired the South San Francisco site from Charles River Laboratories International, supporting its technology portfolio and broadening its international presence with a biotechnology hub in the US.
The US Food and Drug Administration (FDA) has approved Celltrion’s Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), the biosimilars referencing Amgen’s Prolia and Xgeva, respectively.
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Novartis' Fabhalta (iptacopan) to treat the adult population with C3 glomerulopathy (C3G).
The US Food and Drug Administration (FDA) has granted fast track designation for Avobis Bio’s lead therapeutic candidate, AVB-114, for treating Crohn's perianal fistulas.
China’s National Medical Products Administration (NMPA) has granted approval to the new drug application (NDA) of Shanghai Fosun Pharmaceutical Industrial Development’s phosphate absorption inhibitor, Tenapanor Hydrochloride tablets, intended for controlling levels of serum phosphorus in dialysis patients with chronic kidney disease (CKD).
Health Canada has granted marketing authorisation to Kashiv BioSciences’ long-acting G-CSF biosimilar, Pegfilgrastim injection.
Biocon Biologics, a subsidiary of Biocon, has launched Yesintek (ustekinumab-kfce), a biosimilar to Stelara, in the US.
Tiziana Life Sciences has entered into a product development services agreement with US contract development and manufacturing organisation (CDMO) Renaissance Lakewood aimed at improving the present formulation and enhancing the production of intranasal foralumab.
The Japan’s Ministry of Health, Labour and Welfare has granted approval to Genmab's Epkinly (epcoritamab) for treating individuals with relapsed or refractory (R/R) follicular lymphoma who have undergone at least two prior therapies.
Biotechnology company Nona Biosciences has entered into a licensing agreement with the University of Alabama at Birmingham (UAB) to advance its B cell development research.
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