FDA approves SetPoint Medicals SetPoint System, a novel neurostimulation device to treat some rheumatoid arthritis patients.
FDA commissioner Martin Makary pushes the idea that the National Institutes of Health funded the Wuhan, China, lab from which the Covid-19 virus escap...
FDA has released the form FDA-483 issued with 15 observations from an inspection at the Jubilant HollisterStier drug manufacturing facility in Kirland...
FDA clears a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram, photoplethysmogram,...
FDA publishes a guidance explaining the process it uses to determine and qualify a MDUFA small business.
FDA grants Vivace Therapeutics an orphan drug designation for VT3989 and its use in treating mesothelioma.
Top House Democrats on the Energy and Commerce Committee raise alarm over what they describe as a coordinated effort by the Trump Administration to re...
FDA issues an online statement summarizing all its concerns with unapproved versions of GLP-1 weight loss drugs being marketed to U.S. consumers.
