FDA clears a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram, photoplethysmogram,...
FDA says the Innovative Science and Technology Approaches for New Drugs pilot is transitioning into a permanent drug development tool qualification pr...
Politico reports that despite strong support from FDA commissioner Martin Makary and HHS secretary Robert F. Kennedy, Jr., President Trump insisted th...
U.S. Senators Ted Budd (R-NC) and Martin Heinrich (D-NM) introduce a bipartisan amendment to FDAs fiscal year 2026 spending bill to strengthen the age...
FDA orders new mandatory safety labeling changes for all opioid analgesics, a move aimed at curbing long-term misuse of the products.
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...
