Type 1 Diabetes
Mar 17, 2026
Sana Biotechnology Reveals Long-Term Positive Data from Type 1 Diabetes Islet Cell Transplant Trial; Bayer’s Finerenone Demonstrates Efficacy in Phase III FIND-CKD Study in Non-Diabetic CKD Population; Immutep Halts Phase III NSCLC Trial; REGENXBIO’s RGX-202 Demonstrates Promising Interim Results in Phase I/II AFFINITY DUCHENNE Trial; Ultragenyx’s DTX301 Gene Therapy Delivers Positive 36-Week Phase 3 Data
Sana Biotechnology Reports Sustained Positive 14-Month Results from Type 1 Diabetes Islet Cell Transplant Study Without Immunosuppression Sana Biotechnology reported continued positive clinical results from its cell therapy programs, reinforcing its broader strategy of developing engineered cells as medicines. T...
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Feb 18, 2026
Diabetes Care Devices: Transforming Management Through Innovation and Precision
Diabetes care devices are becoming increasingly vital as the global burden of diabetes continues to rise. Today, more than 530 million adults worldwide live with diabetes, a number projected to increase in the future. The condition requires continuous monitoring and timely intervention to prevent serious complicati...
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Jan 13, 2026
Insilico Medicine Moves Garutadustat into Phase IIa Following First Patient Dosing; Sustained Therapeutics Reports Encouraging Phase 2 Outcomes for Long-Acting Non-Opioid Chronic Pain Drug; ZYUS Life Sciences Shares Early Results from Ongoing Phase 2a UTOPIA-1 Pain Trial; Merck Advances KRAS G12C Program With Phase 3 Calderasib Combination Study in NSCLC; Sanofi’s Teizeld Gains EU Approval for Early-stage Type 1 Diabetes
Insilico Medicine Doses First Patient in Phase IIa Trial of Garutadustat for Inflammatory Bowel Disease Insilico Medicine has dosed the first patient in its Phase IIa clinical trial of Garutadustat, an AI-designed small-molecule therapy being developed for Inflammatory Bowel Disease (IBD), specifically ulcerativ...
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Jan 06, 2026
Zenas BioPharma’s Obexelimab Delivers Positive Phase 3 Results in IgG4-RD; Sanofi Secures US Priority Review for Tzield in Pediatric Stage 2 Type 1 Diabetes; Axsome’s AXS-05 sNDA Accepted by FDA with Priority Review for Alzheimer’s Agitation; Vanda’s NEREUS Receives FDA Approval; Omeros’ YARTEMLEA Sets Milestone as First Approved TA-TMA Therapy
Zenas BioPharma Announces Successful Phase 3 INDIGO Study of Obexelimab in IgG4-RD Zenas BioPharma has announced positive top-line results from its pivotal Phase 3 INDIGO clinical trial evaluating obexelimab for the treatment of IgG4-Related Disease (IgG4-RD). IgG4-RD is a rare, systemic, chronic fibroinflammato...
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Mar 18, 2025
FDA Expands SOLIRIS for Pediatric Myasthenia Gravis; vTv’s Cadisegliatin Program Resumes as FDA Lifts Hold; ENCell’s EN001 Wins Orphan Drug Designation for Charcot-Marie-Tooth; FDA Accepts Sydnexis’ NDA for SYD-101 in Pediatric Myopia; Cambium Bio’s Potency Assay Strategy Cleared for Elate Ocular Phase III Trials
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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Jan 14, 2025
Agios’ PYRUKYND SNDA Accepted by FDA for Thalassemia; BridgeBio’s BBO-8520 Gets FDA Fast Track for KRASG12C-Mutated Lung Cancer; Nipocalimab Granted FDA Priority Review for Myasthenia Gravis; Rigel’s R289 Receives FDA Orphan Drug Designation for MDS; Rise Therapeutics Gets FDA IND Clearance for R-5780 in Cancer
FDA Accepts Agios’ SNDA for PYRUKYND in Thalassemia Patients Agios Pharmaceuticals, Inc. announced that the FDA has accepted its supplemental New Drug Application (sNDA) for PYRUKYND® (mitapivat) to treat adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The appl...
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Mar 05, 2024
Bayer’s New Cardiology Drug Acoramidis; Two Datopotamab Deruxtecan Applications Validated in the EU; AbbVie and OSE Immunotherapeutics Announce Announces Partnership; vTv Therapeutics Makes Major Move With Cadisegliatin; A2 Bio Scores FDA Orphan Drug Designation for its Therapy, A2B530; FDA Fast Track Designation for AlloNK® in Lupus Nephritis
Acoramidis Joins Bayer's Robust Lineup, Boosting Cardiology Solutions Bayer has obtained the exclusive rights to market acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH, and BridgeBio Europe B.V. Acoramidis, a highly potent and selective small molecule given orally, functions as a ...
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Jul 04, 2023
First Gene Therapy for Severe Hemophilia A; FDA Approves CellTrans’s Type 1 Diabetes Cellular Therapy; FDA Approve Amneal’s Parkinson’s Drug Over Safety Concerns; NLS Pharmaceutics’s Phase III Clinical Trials of Quilience; Genenta Science’s Temferon for the Treatment of Glioma; FDA Fast Track Designation to GSK’s Gonorrhea Drug
FDA Approves First Gene Therapy for Severe Hemophilia A BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, announced that the US Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the tr...
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May 01, 2023
Cell and Gene Therapies for Diabetes Treatment: A Permanent Cure for Patients?
Diabetes is the 8th largest cause of death in the United States (although its prevalence may be underreported). Diabetes affects more than 37 million people in the United States, and 1 in every 5 are unaware of their condition. Over 96 million US adults—more than one-third—have prediabetes, and more than 8 out of 1...
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Jul 19, 2022
Byondis’s HER2-targeting ADC trastuzumab duocarmazine; AbbVie Migraine Drug Atogepant; Grünenthal Acquires Bayer’s Testosterone Drug Rights; Vertex Acquires ViaCyte; Merck & Orion Announces Collaboration; Verve Starts Trials of Cholesterol Drug; Kyowa Kirin Drops Nourianz follow-up KW-6356; FDA Orphan Drug and Fast Track Designations to CV-01
Byondis Files its HER2-Targeting Antibody-Drug Conjugate (ADC) Trastuzumab Duocarmazine in the US and Europe Byondis has filed for clearance of its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the United States and Europe, setting up a battle with heavyweight competitors Roche and Ast...
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