FDA approves a Moderna sBLA for its Spikevax Covid-19 vaccine for children aged six months to 11 years old who are at increased risk for Covid-19.
The House Energy and Commerce Health Subcommittee schedules a 7/16 hearing on preserving access to timely and affordable care.
AirLife recalls certain lots of its Broselow Pediatric Emergency Rainbow Tape because they were manufactured with incorrect information on the device.
FDA approves an updated dosing schedule for Eli Lillys Alzheimers therapy Kisunla (donanemab-azbt) to reduce the risk of a known side effect called am...
FDA warns Vineyard, UT-based Dynamic Blending Specialists about multiple violations in its work as a contract manufacturer of over-the-counter drug pr...
FDA warns Berkeley, CA-based Libby Laboratories about CGMP violations in its manufacturing of finished drugs.
University of Illinois law school scholar Sara Gerke calls for FDA to create AI Facts labeling for artificial intelligence-powered medical devices.
A Foundation for Defense of Democracies paper calls on FDA to correct a gap in a recent guidance that makes in-use medical devices vulnerable to cyber...
