FDA approves Ionis Pharmaceuticals’ Zanvastro (zilganersen) injection for treating Alexander disease in pediatric and adult patients.
A Crowell & Moring analysis says FDA may increase regulatory scrutiny for user-facing GenAI-enabled devices.
FDA approves Ionis Pharmaceuticals’ Zanvastro (zilganersen) injection for treating Alexander disease in pediatric and adult patients.
A Crowell & Moring analysis says FDA may increase regulatory scrutiny for user-facing GenAI-enabled devices.
FDA says helping to increase supplies of estradiol transdermal patches after reports that some patients are having difficulty finding their usual products at pharmacies.In a 9/3 update`
FDA grants Heartvue.ai a 510(k) clearance for its Heartvue.Proton, a machine learning–powered software for viewing, post-processing, and quantitative evaluation of cardiovascular magnetic resonance images.
