EMA Links Semaglutide to Rare Vision Loss Risk
Two-fold increased risk prompts label updates for blockbuster GLP-1 drugs.
Regulatory
Randox Gains FDA De Novo Clearance for Hemophilia CDx
Randox Laboratories has secured FDA de novo clearance for its ConcizuTrace ELISA companion diagnostic, designed to quantify plasma concentrations of Novo Nordisk’s recently approved hemophilia treatment Alhemo (concizumab-mtci). The regulatory milestone comes just weeks after Alhemo received FDA approval in December 2024 as a once-daily prophylactic injection for adults and pediatric patients 12 years and … Read more
LifeScience Weekly Digest: Key Industry Updates (13th – 17th January)
JP Morgan Week featured notable developments in drugs, devices, diagnostics, and digital health. Johnson & Johnson paid $14.6 billion for Intra-Cellular Therapies, bolstering its neuroscience portfolio with CAPLYTA® and a strong mental health pipeline. Eli Lilly invested $2.5 billion in Scorpion Therapeutics’ PI3Kα inhibitor for hormone-positive breast cancer, while Bausch + Lomb expanded ophthalmology with … Read more