FDA grants Reflow Medical a breakthrough device designation for the Temporary Spur Stent System, a novel retrievable stent technology intended for tre...
FDA approves a MicroVention PMA for the FRED (Flow Re-Direction Endoluminal Device) device for treating brain aneurysms.
The Coalition to Preserve Access to Pharmacogenomics Information petitions FDA urging it to stop enforcement actions against genetic tests that claim ...
Alnylam Pharmaceuticals begins a rolling submission of its NDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for trea...
FDA says Appco and Northwind have recalled ranitidine and Mylan has recalled nizatidine due to potential NDMA contamination.
Regeneron reports positive results from the LUMINA-1 trial of its garetosmab in treating fibrodysplasia ossificans progressiva.
Health IT News reports that Google is making the FDA MyStudies open-source platform available on Google Cloud.
FDA approves a Blueprint Medicines NDA for Ayvakit (avapritinib) for treating certain adults with unresectable or metastatic gastrointestinal stromal ...