Neurizon Therapeutics Limited has received clearance from the United States Food and Drug Administration for its investigational therapy NUZ-001 to be included in the HEALEY ALS Platform Trial, a globally recognized adaptive trial framework for amyotrophic lateral sclerosis. The decision formally designates NUZ-001 as Regimen I in the platform, allowing clinical site activation and study […]
Anixa Biosciences Inc. has reported final Phase 1 results for its investigational breast cancer vaccine targeting the α-lactalbumin protein, showing that the primary endpoints were met and 74 percent of participants demonstrated protocol-defined immune responses. The data were presented at the 2025 San Antonio Breast Cancer Symposium and build the case for a Phase 2 […]
A new phase III clinical trial published in The Lancet has shown that proton therapy significantly improves overall survival and reduces treatment-related toxicities in patients with oropharyngeal cancers compared to traditional photon-based radiation. Conducted across 21 U.S. institutions and led by researchers at the University of Texas MD Anderson Cancer Center, the study is the […]
Amgen has received approval from the United States Food and Drug Administration for Uplizna (inebilizumab-cdon) to treat adults with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive. The greenlight makes Uplizna the first and only CD19-targeted B cell therapy approved for this patient population, introducing a twice-yearly dosing regimen […]
Innovent Biologics has reported that mazdutide, its dual GLP-1 and glucagon receptor agonist, achieved statistically significant reductions in both body mass index and weight in Chinese adolescents with obesity during a 12-week Phase 1b clinical trial. The trial met its primary endpoint, demonstrated a favorable safety profile, and paves the way for a Phase 3 […]
Akeso Inc. has secured clearance from the United States Food and Drug Administration to initiate COMPASSION-37, a global Phase III trial evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, as part of a first-line treatment regimen for HER2-negative, unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma. The randomized, multicenter trial will compare cadonilimab plus chemotherapy against […]
Orphalan, the international pharmaceutical company known for developing orphan drugs, has announced the acquisition of Orphelia Pharma, a specialist in rare and severe pediatric diseases. The deal enhances Orphalan’s position in the European rare disease market, particularly within pediatric neurology and oncology, and signals a strategic pivot toward deeper vertical integration in pediatric formulations and […]
STADA Arzneimittel AG and Bio-Thera Solutions have secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gotenfia, a proposed biosimilar to the tumor necrosis factor alpha inhibitor golimumab. The product references Simponi, an originator drug widely prescribed for multiple autoimmune conditions. If approved, Gotenfia would be marketed […]
Marengo Therapeutics has presented early-stage results from its STARt-002 clinical trial evaluating invikafusp alfa (Invika), a novel T cell immunotherapy candidate, in combination with sacituzumab govitecan (TRODELVY), an antibody-drug conjugate developed by Gilead Sciences. The data, shared during a late-breaking presentation at the 2025 San Antonio Breast Cancer Symposium, highlight the safety, pharmacodynamic activity, and […]
Insilico Medicine has licensed its AI-discovered oral PHD inhibitor ISM4808 to TaiGen Biotechnology for exclusive development and commercialization in the Greater China region, including Mainland China, Hong Kong, Macau, and Taiwan. The deal follows Investigational New Drug clearance in China in 2023 and positions TaiGen to bring the asset into clinical trials targeting anemia associated […]