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A RAPS publication says FDA is likely to publish a draft guidance on plans for clinical trial diversity by the end of this year.[ Price : $8.95]
FDA clears a Hyperfine 510(k) for updated software for its portable magnetic resonance brain imaging system, the Swoop system.[ Price : $8.95]
FDA posts a final guidance entitled Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.[ Price : $8.95]
FDA approves Medtronics next-generation SynchroMed III intrathecal drug delivery system for patients with chronic pain, cancer pai...[ Price : $8.95]
Merck says the Phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as a perioperative treatment regimen for patients wit...[ Price : $8.95]
Federal Register notice: FDA publishes a list of 18 information collections that have been approved by OMB.[ Price : $8.95]
FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for Eli Lillys Retevmo (selp...[ Price : $8.95]
FDA sends Alnylam Pharmaceuticals a complete response letter on a supplemental NDA for Onpattro (patisiran) for treating cardiomyo...