Zynex files a 510(k) for its NiCO, Noninvasive CO-Oximeter device that relies on the companys laser technology.
Moderna, at FDAs urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.
FDA warns Holliston, MA-based NeuroSync about Quality System regulation and other violations in its manufacturing of the Eye-Sync eye assessment medic...
Johnson & Johnsons Ethicon Endo-Surgery recalls its Endopath Echelon Vascular White Reload for Advanced Placement Tip surgical stapler due to increase...
FDA publishes 34 new and 14 revised product-specific guidances to aid in generic drug development.
FDA names Elizabeth Miller acting associate commissioner of the Office of Inspections and Investigations (OII), replacing Michael Rogers, who retired ...
The CDER Office of Prescription Drug Promotion warns Sarfez Pharmaceuticals that promotional materials for its Soaanz edema drug contain false and mis...
FDA commissioner Marty Makary and CBER director Vinay Prasad outline a new regulatory framework for annual Covid-19 booster shots and call for new cl...
