China's Leads Biolabs Wins FDA Nod to Begin First-in-Human Trial of Novel Autoimmune Therapy
The US Food and Drug Administration (FDA) has approved Leads Biolabs’ first-in-human Investigational New Drug (IND) application for LBL-047, a novel therapeutic candidate for the treatment of autoimmune diseases such as systemic lupus erythematosus, dermatomyositis, IgA nephropathy and Sjögren's syndrome.
Clinical Trials | 22/09/2025 | By Dineshwori | 364
Wegovy (Semaglutide 2.4 mg) reduced risk of heart attack, stroke, or death by 57 percent when compared to Tirzepatide, and 29 percent across all patients, showing heart-protective benefits unique to the Semaglutide molecule.
Clinical Trials | 19/09/2025 | By Dineshwori | 243
Aurobindo's Subsidiary CuraTeQ Biologics Completes Phase 3 Clinical Study for Denosumab Biosimilar
CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has successfully completed a pivotal clinical study of its denosumab biosimilar, evaluated against Amgen’s Prolia in 446 women with postmenopausal osteoporosis.
Clinical Trials | 19/09/2025 | By Dineshwori | 406
Greenwich LifeSciences Expands Flamingo-01 Breast Cancer Trial to Ireland
Greenwich LifeSciences has expanded its Phase III clinical trial, FLAMINGO-01, evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, to Ireland.
Clinical Trials | 18/09/2025 | By Dineshwori | 175
Novo Nordisk presented new findings from its Wegovy and Cagrilintide trials in obesity management at the ongoing European Association for the Study of Diabetes (EASD) 2025 congress in Vienna, Austria.
Clinical Trials | 17/09/2025 | By Dineshwori | 480
Gyala Therapeutics Unveils CD84 CAR-T with Strong Pre-clinical Results in Tough Leukemias
Gyala secures €3 million financing from Invivo Partners, Nara Capital and CDTI Innvierte to launch a Phase I trial in AML patients in H2 2025
Clinical Trials | 17/09/2025 | By Dineshwori | 155
BioAge Labs Initiates Phase 1 Trial of Novel NLRP3 Inhibitor BGE-102 for Obesity Treatment
BioAge Labs, a clinical-stage biotechnology company based in Emeryville, California, has announced the initiation of a Phase 1 clinical study of BGE-102, an orally available, brain-penetrant small molecule NLRP3 inhibitor being developed for the treatment of obesity.
Clinical Trials | 16/09/2025 | By Dineshwori | 248
Akeso Doses First Patient in Global Trial of Cadonilimab for PD-1 Resistant Liver Cancer
COMPASSION-36, the first global Phase III trial of Cadonilimab, is underway in China, the US, and Europe. It marks a key step in Akeso's effort to advance cancer immunotherapy beyond single-target treatments.
Clinical Trials | 15/09/2025 | By Dineshwori | 255
Phrontline Biopharma Announces First Patient Dosed in Phase-I Clinical Trial of TJ101
The Phase 1 study of TJ101 will assess its safety, tolerability, pharmacokinetics, and early anti-tumor activity in various solid tumors, using a dose escalation and expansion cohort design.
Clinical Trials | 15/09/2025 | By Dineshwori | 124
NMPA Clears Zhimeng Biopharma's Drug for Phase-II Epilepsy Trial
Zhimeng Biopharma’s drug for Phase II epilepsy trial will be evaluated in a randomized, double-blind, placebo-controlled multinational study to test its efficacy, safety, and tolerability as an adjunct therapy in adults with focal epilepsy.
Clinical Trials | 13/09/2025 | By Dineshwori | 205
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