Endocrinology and Metabolic Disorders

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Madrigal Wins EU Approval for REZDIFFRA in MASH With Liver Fibrosis; Valneva Faces FDA License Suspension for Chikungunya Vaccine IXCHIQ; Coya Secures FDA IND Clearance for COYA 302 in ALS Treatment; Rusfertide Earns FDA Breakthrough Therapy Designation for Polycythemia Vera; Crinetics Gains FDA Orphan Drug Status for Atumelnant in Congenital Adrenal Hyperplasia

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CagriSema Shows Strong Dual-Hormone Promise in Obesity and T2D: Key Findings from REDEFINE Trials

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Cardiovascular Outcomes and Efficacy of the PCSK9 Inhibitor Evolocumab in Individuals With T1D: Insights From the FOURIER Trial

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Merck’s WINREVAIR Granted FDA Priority Review for Pulmonary Arterial Hypertension; KalVista’s EKTERLY Approved by FDA as First Oral On-Demand Therapy for Hereditary Angioedema; Fujifilm’s FF-10832 Receives FDA Orphan Drug Designation for Biliary Tract Cancer; Mustang Bio’s MB-101 Granted FDA Orphan Drug Designation for Glioblastoma and Astrocytomas; Denali’s Tividenofusp Alfa Accepted for FDA Priority Review for Hunter Syndrome

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Amylyx’s AMX0114 Fast Tracked by FDA for ALS; Cellectar’s Iopofosine I 131 Granted FDA Breakthrough in Waldenstrom Macroglobulinemia; YolTech’s YOLT-101 Clears FDA IND for Familial Hypercholesterolemia; Oncovita’s MVdeltaC Gets FDA Orphan Tag for Pleural Mesothelioma; Merck’s ENFLONSIA Approved for RSV Prevention in Infants

Mobile Apps for Chronic Diseases Management

Assessing the Growing Role & the Demand of Chronic Disease Management Apps

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FDA Clears Fujirebio’s Lumipulse® G Plasma Test for Detecting Alzheimer’s-Linked Amyloid Pathology; Stryker Gains FDA Clearance for OptaBlate® BVN System to Treat Chronic Low Back Pain; Abbott Unveils Clinical Evidence Linking Libre® CGM to Reduced Cardiovascular Events in Diabetes; GE HealthCare Launches AI-Based CleaRecon DL for Enhanced 3D Reconstruction in Interventional Suites; Philips Advances Cardiac Care with Launch of RADIQAL Clinical Study and Real-Time 3D Intracardiac Imaging Catheter in Europe

Unveiling Lysosomal Storage Disorders_ Exploring Rare Diseases Impacting Millions Worldwide

Unveiling Lysosomal Storage Disorders: Exploring Rare Diseases Impacting Millions Worldwide

Generative AI in Drug Discovery_ Applications and Market Impact

Generative AI in Drug Discovery: Applications and Market Impact

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Eli Lilly’s ZEPBOUND Surpasses WEGOVY in SURMOUNT-5 Trial; Verastem Oncology Secures FDA Approval for AVMAPKI + FAKZYNJA in KRAS-Mutant Ovarian Cancer; Thermosome Gains Orphan Drug Designation for THE001; Beam Therapeutics Receives RMAT Status for BEAM-302 in AATD; Capsida Biotherapeutics Gets IND Clearance for STXBP1 Gene Therapy

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Teleflex Receives FDA 510(k) Clearance to Expand Use of QuikClot Control+™; Edwards Wins FDA Nod for TAVR Use in Asymptomatic Aortic Stenosis; LivaNova Announces Positive 12-Month Results from OSPREY Study in Moderate to Severe OSA; Lipogems Completes Final Patient Visit in ARISE 1 Knee Osteoarthritis Trial; Roche Launches Advanced Elecsys PRO-C3 Test for More Accurate Liver Fibrosis Grading; iRhythm Introduces Zio® Long-Term ECG Monitoring in Japan, Enhancing AI-Driven Arrhythmia Detection

Abeona Secures FDA Nod for ZEVASKYN, the First Gene Therapy for RDEB; AbbVie Gains FDA Approval for RINVOQ in Giant Cell Arteritis; Lantern Pharma Advances LP-184 with IND Clearance for TNBC Trial; Ichnos Glenmark Earns FDA Fast Track for ISB 2001 in Multiple Myeloma; Rezolute Wins Breakthrough Therapy Designation for Ersodetug in Tumor-Induced Hypoglycemia

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Boston Scientific Pushes Forward Despite $200M Tariff Challenge; Northstrive Biosciences Gets FDA Green Light to Advance EL-22 Obesity Trial; Roche Acts Swiftly to Offset U.S. Tariff Impact with Global Engagements; Verastem Oncology Secures IND Clearance for KRAS G12D Inhibitor Trial; BlackfinBio Gets FDA OK for Phase I/II Trial of BFB-101 in SPG47

medtech-news-for-medtronic-elutia-bd

FDA Approves Simplera Sync™ Sensor for MiniMed™ 780G System; BVI Medical Secures FDA 510(k) Clearance for Leos™ Laser Endoscopy System in Ophthalmology; Surmodics Announces TRANSCEND Trial Data Supporting SurVeil™ Drug-Delivery Platform; Elutia Launches EluPro™ Registry Study to Gather Real-World Clinical Data; BD Launches Next-Generation AI-Driven Hemodynamic Monitoring and Industry-First Bioabsorbable Mesh for Umbilical Hernia Repair

feature-Non-Surgical Body Contouring_ What’s Fueling Its Growth in Aesthetic Medicine

Non-Surgical Body Contouring: What’s Fueling Its Growth in Aesthetic Medicine?

emerging-obesity-targeted-therapies-for-mash

Redefining Liver Disease in the Metabolic Era: From NASH to MASH and the Rise of Obesity‐targeted Therapies

mps-i-treatment-pipeline

Mucopolysaccharidosis Type I Treatment Pipeline — 4 Promising Therapies on the Way

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