Advanced Melanoma
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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Feb 26, 2024
Iovance’s Breakthrough: Amtagvi Paves the Way for Cell Therapies in Solid Tumors
The category of T-cell therapy, which revolutionized the management of specific blood cancers, has now extended its impact to solid tumor treatment with the approval from the FDA of a groundbreaking immunotherapy pioneered by Iovance Biotherapeutics. Known as Amtagvi or lifileucel, this medication marks the debut o...
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Feb 20, 2024
FDA Approves Xolair for Food Allergies; FDA Accelerated Approval for Iovance’s AMTAGVI; Astellas and Kelonia Enter into Research and License Agreement; Fast Track Designation to Certa’s FT011; Innovent Announces Phase 3 Clinical Trial Updates for IBI311; Orphan Drug Designation to Cardiol’s Pericarditis Drug Candidate
FDA Approves Xolair as First and Only Medicine for Children and Adults with One or More Food Allergies Roche has announced that the FDA has approved Xolair® (omalizumab) to mitigate allergic responses, such as anaphylaxis, that may arise from accidental exposure to various foods in both adult and pediatric patie...
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Mar 28, 2023
Novartis Announces the Positive Results of Phase III NATALEE Trial Evaluating Kisqali; FDA Approves Pharming’s Joenja for APDS; FDA Orphan Drug Designation to Cyclerion’s Zagociguat; Iovance Completes BLA Submission for Lifileucel in Advanced Melanoma; BPGbio Announces Partnership with debra of America
Novartis Announces the Positive Results of Phase III NATALEE trial Evaluating Kisqali Novartis announced positive topline results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali® (ribociclib) plus endocrine therapy (ET) in a broad population of patients with hormone receptor-positive/hu...
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