Mar 18, 2025
MDA Applauds FDA’s Expanded Approval of Soliris for Pediatric Generalized Myasthenia Gravis The Muscular Dystrophy Association (MDA) celebrates the FDA approval of an expanded indication for Alexion/AstraZeneca’s eculizumab (Soliris), now authorized for pediatric patients aged six and older with generalized myas...
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Mar 17, 2025
The global obesity crisis has sparked a multibillion-dollar showdown in the pharmaceutical world, with Novo Nordisk and Eli Lilly locked in an intense battle for supremacy. These industry titans are redefining the weight loss drug market with groundbreaking GLP-1 therapies. Novo Nordisk’s WEGOVY (semaglutide) and E...
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Mar 13, 2025
Caristo Wins FDA Clearance for AI Solution to Prevent Heart Attacks Caristo Diagnostics, focused on transforming the diagnosis and treatment of cardiovascular disease, has announced that its CaRi-Plaque technology has received 510(k) clearance from the FDA. CaRi-Plaque is an AI-powered image analysis tool design...
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Mar 14, 2025
The success of CAR-T therapies like Bristol-Myers Squibb/Bluebird bio’s ABECMA and Janssen’s CARVYKTI is reshaping treatment paradigms, challenging traditional options like stem cell transplants and proteasome inhibitors. The multiple myeloma market size in the US is responding rapidly from ~USD 15 billion, with in...
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Mar 12, 2025
Obesity isn't just a personal struggle; it's a worldwide epidemic affecting over 1 billion people. This alarming statistic highlights an urgent need for effective interventions, as obesity dramatically raises the risk of life-threatening conditions like type 2 diabetes, heart disease, sleep apnea, and even certain ...
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Mar 11, 2025
Neurotech’s ENCELTO Becomes First FDA-Approved Treatment for Macular Telangiectasia Type 2 Neurotech Pharmaceuticals, Inc. has announced that the FDA has approved ENCELTO (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel), a progressive neurodegenerative retinal disease th...
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Mar 10, 2025
For nearly three decades, Genentech has been the sole provider of an approved medication for acute stroke treatment. On 03 March 2025, the Roche subsidiary expanded its stroke treatment portfolio with FDA approval for TNKase (tenecteplase). TNKase (tenecteplase) is a thrombolytic, clot-dissolving tis...
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Mar 07, 2025
On March 3, 2025, BeiGene secured another approval for its anti-PD-1 antibody, TEVIMBRA, as the FDA granted clearance for its use in combination with platinum-based chemotherapy as a first-line treatment for adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1....
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Mar 06, 2025
ABANZA Received FDA 510(k) Clearance for WasherCap™ Mini Implantable Fixation Device, Advancing Soft Tissue Repair Solutions On February 26, 2025, ABANZA, a leader in advanced soft tissue repair solutions announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its innovative...
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Mar 05, 2025
Major Depressive Disorder (MDD) is a widespread and debilitating psychiatric condition that continues to challenge patients, caregivers, and healthcare systems worldwide. Characterized by persistent sadness, loss of interest, cognitive dysfunction, and suicidal ideation, MDD remains a major public health concern. D...
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