FDA accepts for priority review an Intellia Therapeutics BLA for lonvo-z, an in vivo CRISPR-based therapy for treating hereditary angioedema.
FDA acknowledges that Bristol Myers Squibbs accelerated approval of Krazati (adagrasib) in combination with cetuximab for adults with previously treat...
HHS names CDER acting director Michael Davis and CBER acting director Karim Mikhail as permanent directors of their respective offices.
There appears to be growing opposition to FDA commissioner nominee Heidi Overton, as a letter-writing campaign is underway to block her Senate confirm...
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...
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.
