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...
FDA grants Roche an emergency use authorization for its cobas SARS-CoV-2 nucleic acid test for use on the cobas Liat System.
FDA sends Orphazyme a complete response letter on an NDA for arimoclomol, a heat shock protein amplifier intended for treating Niemann-Pick disease Ty...