Category Regulatory

Takeda Gets EC Approval for ADZYNMA®: First Recombinant ADAMTS13 Therapy for cTTP

Today, the European Commission (EC) approved ADZYNMA®▼ (recombinant ADAMTS13) for treating ADAMTS13 deficiency in both children and adults with congenital thrombotic thrombocytopenic purpura (cTTP). ADZYNMA is now the first and only enzyme replacement therapy in the European Union (EU) specifically…

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Novartis Wins FDA Approval for Fabhalta®, First Complement Inhibitor for IgAN

Novartis announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta® (iptacopan), a first-in-class complement inhibitor designed to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This…

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Alzamend Neuro and Mass General Launch Phase II Trial of AL001 for Alzheimer’s

Alzamend Neuro, a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, announced its partnership with Massachusetts General Hospital (Mass General) to conduct a Phase II clinical trial of…

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U.S. Oligonucleotide Synthesis Market Report 2024-2030: Trends, Shares, and Analysis

The “U.S. Oligonucleotide Synthesis Market Size, Share & Trends Analysis Report” for 2024-2030 has been added to ResearchAndMarkets.com’s portfolio. This report forecasts that the U.S. oligonucleotide synthesis market will reach USD 3.09 billion by 2030, growing at a CAGR of…

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Agilent Gains FDA Approval for MAGE-A4 IHC 1F9 pharmDx as a Diagnostic Tool for New TCR T-Cell Therapy

Agilent has announced that it has received FDA approval for the MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to identify patients with synovial sarcoma who may qualify for treatment with TECELRA® (afamitresgene autoleucel, also known as afami-cel or…

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FDA Approves Roche’s Vabysmo Prefilled Syringe for Three Major Causes of Vision Loss

The United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for treating neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion…

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