mAbxience and Amneal Pharmaceuticals have secured U.S. Food and Drug Administration (FDA) approval for two denosumab biosimilars, Boncresa and Oziltus, referencing Prolia and XGEVA respectively, clearing a long-anticipated regulatory hurdle in osteoporosis and oncology supportive care. The approvals position Amneal Pharmaceuticals as the exclusive U.S. commercial partner, with mAbxience responsible for development and manufacturing, marking […]
GenSight Biologics S.A. has received approval from Israel’s Ministry of Health to provide early access treatment with its investigational gene therapy GS010/LUMEVOQ (lenadogene nolparvovec) for individual patients diagnosed with ND4-related Leber Hereditary Optic Neuropathy (LHON). This authorization permits bilateral intravitreal injections under compassionate use protocols, with treatments expected to begin in the first quarter of […]
Incyte Biosciences Japan has secured approval from the Ministry of Health, Labour and Welfare for the use of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma. This marks the first regulatory authorization in Japan for a CD19-directed therapy in this indication and introduces a novel CD19–CD20 […]
Samsung Bioepis has officially begun direct commercialization of BYOOVIZ, a biosimilar to Lucentis (ranibizumab), across Europe following the complete transfer of rights from Biogen. The move makes BYOOVIZ the fourth biosimilar now independently marketed by Samsung Bioepis in the region, joining EPYSQLI (eculizumab), OBODENCE (denosumab), and XBRYK (denosumab). The company also confirmed that a pre-filled […]
Hoth Therapeutics, Inc. has filed two provisional U.S. patents for its investigational therapy HT-001, aiming to address skin toxicities caused by radiation and targeted cancer therapies. The dual filings mark a deliberate expansion into oncology-adjacent dermatology, establishing a new intellectual property footprint around treatment-induced skin damage, including adverse effects linked to menin inhibitors. This signals […]
Palisade Bio’s PALI-2108 secures a Japanese patent. Explore how this gut-targeted PDE4 inhibitor could change the game in ulcerative colitis and Crohn’s.
BioAtla and GATC Health advance Ozuriftamab Vedotin into a Phase 3 trial for OPSCC via SPV financing. Discover how this targets cancer and aging together.
Valneva ends its chikungunya vaccine deal with Serum Institute of India. Find out what this means for Asian access, LMIC rollout, and CEPI commitments.
FDA rejects Outlook Therapeutics’ ONS-5010 for wet AMD again. Find out what this means for U.S. approval and how European expansion could reshape strategy.
