FDA clears a Biotricity 510(k) for its Biotres Cardiac Monitoring Device, a three-lead holter device for electrocardiogram and arrhythmia monitoring.
FDA grants Cook Medical a breakthrough device designation for its new drug-eluting stent for below the knee use.
The RWE Alliance suggests that FDA increase communications with external stakeholders about concrete real-world evidence use cases.
FDA revises Eli Lillys emergency use authorization for bamlanivimab and etesevimab and Regenerons emergency use authorization for Regen-Cov (casirivim...
Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance on Reagents for Detection of Specific Novel Influ...
Federal Register notice: FDA seeks comments on an information collection extension entitled Exports Notification and Recordkeeping Requirements 21 CF...
FDA issues Merck a complete response letter on its NDA for gefapixant, an orally administered selective P2X3 receptor antagonist for treating refracto...
FDA places a clinical hold on a Viking Therapeutics Phase 1b clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy.