FDA approves a Medtronic PMA supplement for expanded approval for its Arctic Front Cardiac Cryoablation Catheters to include treating recurrent sympto...
FDA sends an untitled letter to NatureWorks (Poulsbo, WA) after reviewing certain Web sites and determining its cell therapy is not licensed for the s...
Masimo gains 510(k) clearance for its Radius T, a wearable, wireless thermometer that measures body temperature continuously.
James Chadwick Brooks (Norcross, GA) and his company CCB Nutrition plead guilty to introducing an unapproved new drug into interstate commerce.
Tarsus Pharmaceuticals plans an NDA submission next year after just reporting positive data from a trial that evaluated the companys lotilaner ophthal...
FDA Review posts the Federal Register notices for the week ending 6/18/2021.
Senator Joe Manchin (D-WV) tells President Biden that he needs to nominate someone other than acting commissioner Janet Woodcock for the top post at F...
FDA grants Spinologics a breakthrough device designation for its MIScoli system, a vertebral body tethering device to treat scoliosis in young adolesc...