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Endocrinology and Metabolic Disorders

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Orforglipron at American Diabetes Association (ADA): Pioneering the Next Generation of Oral, Nonpeptide GLP-1 Therapies

A new oral anti-diabetes pill, orforglipron, shows similar effectiveness to injectable GLP-1 drugs in a Phase III trial. Orforglipron significantly reduced A1c over 40 weeks in adults with early Type 2 diabetes, according to the results of ACHIEVE-1. At ADA 2025, Eli Lilly showcased promising Phase III data for orforglipron, a novel, oral, non-peptide GLP-1 receptor agonist, reinforcing its potential to transform the treatment paradigm for type 2 diabetes. With five ongoing studies in Type II diabetes (T2D) and two in obesity, the company aims to file for obesity approval by Q4 2025 and T2D in H1 2026. ADA 2025 Coverage Abstract: Orforglipron Phase III Tria...

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Durable Glycemic Control and Elimination of Exogenous Insulin Use with Zimislecel (VX-880) in Patients with Type 1 Diabetes (T1D)—VX-880-101 (FORWARD)

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Once-monthly MariTide for the Treatment of Obesity in People with or without T2D: A 52-Week Phase II Study

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MET-097i: A Fully Biased Ultra-long Acting GLP-1 Receptor Agonist

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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

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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