Systemic Mastocytosis
Oct 21, 2025
FDA Approves Genentech’s GAZYVA for Lupus Nephritis; Glaukos’ EPIOXA Wins FDA Approval for Keratoconus Treatment; FDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma; Cogent’s Bezuclastinib Earns FDA Breakthrough Therapy for SM-AHN; Amgen’s TEZSPIRE Gets FDA Nod for Chronic Rhinosinusitis with Nasal Polyps
FDA Approves Genentech’s GAZYVA for Lupus Nephritis Genentech, a member of the Roche Group, announced that the FDA has approved GAZYVA (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) receiving standard therapy. The approval is supported by data from the Phase II NOBILITY and P...
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