FDA posts a final guidance entitled Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.
FDA approves Medtronics next-generation SynchroMed III intrathecal drug delivery system for patients with chronic pain, cancer pain, and severe spasti...
Merck says the Phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as a perioperative treatment regimen for patients with resectable Stage I...
Federal Register notice: FDA publishes a list of 18 information collections that have been approved by OMB.
FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for Eli Lillys Retevmo (selpercatinib).
FDA sends Alnylam Pharmaceuticals a complete response letter on a supplemental NDA for Onpattro (patisiran) for treating cardiomyopathy of transthyret...
FDA issues Biocon Biologics a complete response letter on its BLA for insulin aspart.
FDA grants ZKR Orthopedics a breakthrough device designation for its Lift implant technology, which is designed to delay or eliminate the need for kne...
