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 prod...
FDA grants Heartvue.ai a 510(k) clearance for its Heartvue.Proton, a machine learningpowered software for viewing, post-processing, and quantitative e...
FDA grants AstraZenenca an accelerated approval for Etcamah (camizestrant), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (a...
There appears to be growing opposition to FDA commissioner nominee Heidi Overton, as a letter-writing campaign is underway to block her Senate confirm...
Four FDA senior officials explain how the agency is strengthening its good clinical practice oversight in an increasingly globalized clinical trial en...
FDA publishes a request for information on stakeholders views on ways to accelerate botanical drug development.
