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 […]
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 […]
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 […]
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 […]
Peijia Medical has received regulatory approval from the National Medical Products Administration of China for the TaurusTrio Transcatheter Aortic Valve system, a dedicated device for the treatment of native symptomatic severe aortic regurgitation. Developed under an exclusive license from JenaValve Technology, the system is based on the latter’s Trilogy Transcatheter Heart Valve platform and represents […]
Ractigen Therapeutics has initiated human testing of RAG-18, a novel small activating RNA (saRNA) therapeutic candidate for Duchenne muscular dystrophy (DMD), by dosing the first patient in an investigator-initiated trial at Peking Union Medical College Hospital in Beijing. The study is being led by Professor Dai Yi, a recognized expert in neuromuscular disorders, and will […]
KVP International has announced the acquisition of SafePath Laboratories and IVD Research, a diagnostics manufacturer and contract development and manufacturing organization (CDMO) provider headquartered in Carlsbad, California. With this move, KVP International aims to strengthen its footprint in veterinary diagnostics while unlocking the potential to expand into human health markets. This acquisition provides KVP International […]
NanOlogy, LLC, a Texas-based clinical-stage oncology company, has announced the launch of a drug development program focused on diffuse intrinsic pontine glioma, known as DIPG, a universally fatal pediatric brainstem tumor. The company is advancing Large Surface Area Microparticle Cisplatin, or LSAM-cisplatin, designed for stereotactic intratumoral administration in children. Investigational New Drug–enabling studies are underway, […]
Phare Bio and Basilea partner to develop an AI-designed antibiotic for deadly gram-negative infections. Explore what this deal could mean for the future of antimicrobial R&D.