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FDA approves a Vanda Pharmaceuticals NDA for Hetlioz (tasimelteon) capsule and liquid formulations for treating adults and childre...[ Price : $8.95]
Federal Register notice: FDA announces a 12/17 advisory committee meeting to discuss an emergency use authorization request by Mod...[ Price : $8.95]
Federal Register notice: FDA posts five information collections that have been approved by OMB.[ Price : $8.95]
FDA approves a broader indication for Blueprint Medicines Gavreto to treat some thyroid cancers.[ Price : $8.95]
FDA warns West Coast Nuclear Pharmacy about drug compounding violations and drugs produced or held in insanitary conditions.[ Price : $8.95]
FDA publishes questions and answers on developing and using transport media during the Covid-19 pandemic.[ Price : $8.95]
Fujirebio Diagnostics files a 510(k) for the Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for use in asse...[ Price : $8.95]
FDA posts a transcript from a 10/27 CDRH public meeting on reauthorizing the Medical Device User Fee Act program that outlined age...