Posted inPharmaceutical
FDA Approves Tecentriq Combination for Stage III dMMR Colon Cancer
Tecentriq stage III dMMR colon cancer approval: FDA clears atezolizumab plus chemotherapy, with 36-month disease-free survival of 86% vs 76%.
Posted inMedical Device
QIAGEN Expands QIAstat-Dx Bloodstream Infection Testing in the US With New Gram-Negative Panel
QIAstat-Dx bloodstream infection portfolio is complete in the US as QIAGEN wins FDA clearance for a gram-negative panel with 18 resistance markers.
Posted inMedical Device
AI-Powered Surgical Software Market to Reach $24.55 Billion by 2035 at 30.2% CAGR
The AI-powered surgical software market is forecast to grow from $1.75B in 2025 to $24.55B by 2035 at a 30.2% CAGR, per Acumen Research.
Posted inPharmaceutical
FDA Accepts Bayer KERENDIA Application for CKD Without Diabetes
The FDA accepted Bayer’s application to extend KERENDIA to adults with chronic kidney disease without diabetes. FIND-CKD results, risks and next steps.
Posted inBio Technology
Ribo Files EU Trial Application for Obesity siRNA RBD3133
Ribo has filed an EU application for a Phase 1 trial of RBD3133, an INHBE-targeting siRNA for obesity. What the gene evidence shows and what is unknown.
Posted inBio Technology
Andelyn Biosciences and PQP Group Partner on EU and UK Gene Therapy Supply
Andelyn Biosciences and PQP Group will coordinate EU and UK supply of US-made cell and gene therapies, from QP release to import and depot. How it works.
Posted inPharmaceutical
Systech Launches ST15S and ST16P Pharma Packaging Stations
Systech launches ST15S and ST16P stations that combine serialization, aggregation and labelling for drug makers and CDMOs. What they do, what is unknown.
Posted inPharmaceutical
Neurosterix Completes Phase 1 of NTX-253, an M4 Drug for Schizophrenia
Neurosterix completed Phase 1 of NTX-253, an oral M4 modulator for schizophrenia, and plans Phase 2. What was tested and what is not yet public.
Posted inPharmaceutical
Lakewood-Amedex Reports Positive Preclinical Data for Bisphosphocin Antimicrobials
Lakewood-Amedex reports preclinical Bisphosphocin data in urinary and lung infection models, including up to 97% E. coli reduction in rodents.
Posted inPharmaceutical
Axplora Advances Axotecan to Establish European Exatecan Supply for ADC Developers
Axplora completes first R&D batches of exatecan, an ADC payload starting material, aiming for European GMP supply by late 2027.