Curated news and analysis on clinical trials, drug approvals, and medical research.
Shanghai Henlius Biotech received approval from China's National Medical Products Administration to begin a phase 1 clinical trial of HLX316, a B7-H3-targeting sialidase Fc fusion protein for advanced or metastatic solid tumors.
Researchers unveil tumor-intrinsic role of PD-L1 in lung cancer progression and develop systematic method for discovering molecular glues that selectively degrade disease proteins, while advances in immunology research aim to improve care for immune-mediated inflammatory diseases.
Natco Pharma has received CDSCO approval to manufacture and market generic semaglutide injection in India, with a planned March 2026 launch. Eris Lifesciences will commercialize the product through a partnership.
New research from the University of Missouri-Columbia reveals that targeted cancer therapies, including tyrosine kinase inhibitors, antibody-drug conjugates, and CAR-T cell therapies, cause distinct patterns of gastrointestinal injury that are often underrecognized.
Allergic rhinitis demonstrates both protective and risk associations with COVID-19 symptoms, while sublingual immunotherapy modifies respiratory and fever outcomes in patients with the condition.
Total spending on direct-to-consumer prescription drug advertising reached $9 billion in 2024, prompting renewed debate over whether such marketing should be legal. The U.S. and New Zealand remain the only developed nations allowing the practice.
Roche's experimental breast cancer pill giredestrant combined with a CDK4/6 inhibitor failed to meet its primary endpoint in a Phase III trial for first-line treatment of ER-positive, HER2-negative advanced breast cancer, marking a setback for the drugmaker's next-generation hormone therapy program.
The FDA approved navepegritide, a once-weekly injectable therapy for achondroplasia, while phase 3 data showed infigratinib, an investigational oral medication, achieved the highest growth velocity reported in randomized trials for the condition.
Acurx Pharmaceuticals announced a new clinical trial program for ibezapolstat in patients with recurrent C. difficile infection, building on Phase 2 results showing 96% clinical cure rates with no recurrence while sparing the gut microbiome.
GE HealthCare announced FDA 510(k) clearances for its View diagnostic viewer within the Genesis Radiology Workspace and three new Signa MRI systems, including helium-free technology and AI-powered workflow solutions.
The FDA has accepted Roche's new drug application for giredestrant plus everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer following prior endocrine therapy, with a decision expected by December 18, 2026.
Transposase systems are emerging as efficient alternatives to CRISPR-Cas9 for gene editing in biopharmaceutical manufacturing and plant breeding, with studies showing up to 90% efficiency and heritability rates while offering advantages in size and integration capabilities.
The US FDA granted priority review and the European Medicines Agency validated applications for Enhertu as post-neoadjuvant treatment for HER2-positive early breast cancer, based on Phase III trial data showing 53% reduction in recurrence risk.
Three new CRISPR-based therapies show promise for treating heart failure through mitochondrial enhancement, cystic fibrosis via lipid nanoparticle gene insertion, and elevated cholesterol with single-dose gene editing targeting ANGPTL3.
Novo Nordisk dismissed its patent infringement lawsuit against Hims & Hers after the companies reached an agreement to sell branded Wegovy and Ozempic through the Hims platform. The settlement ends a dispute that began when Hims planned to offer a cheaper off-brand version of Wegovy.
Veru Inc. has enrolled the first patient in its Phase 2b PLATEAU clinical trial evaluating enobosarm combined with semaglutide for weight loss in older patients with obesity. The study will assess enobosarm's ability to preserve lean mass and physical function while augmenting fat loss.
AbbVie announced positive Phase 1 results for ABBV-295, a long-acting amylin analog for obesity treatment, showing clinically meaningful weight loss with favorable tolerability across all dose levels tested.
New real-world effectiveness data presented at RSVVW'26 demonstrate that GSK's Arexvy RSV vaccine was associated with a 75.6% reduction in RSV-related hospitalizations among adults aged 60 and older, with exploratory findings suggesting potential benefits for cardiovascular and respiratory complications.
New research demonstrates machine learning can optimize drug dosing, identifies biomarkers of treatment response, and validates prognostic criteria for long-term kidney survival in pediatric lupus nephritis patients.
GSK agreed to license linerixibat to Alfasigma in a deal worth up to $690 million, while Eisai received orphan drug designation in Japan for E2086, a novel selective orexin 2 receptor agonist for narcolepsy.
