Federal Register notice: FDA posts five information collections that have been approved by OMB.
FDA approves a broader indication for Blueprint Medicines Gavreto to treat some thyroid cancers.
FDA warns West Coast Nuclear Pharmacy about drug compounding violations and drugs produced or held in insanitary conditions.
FDA publishes questions and answers on developing and using transport media during the Covid-19 pandemic.
Fujirebio Diagnostics files a 510(k) for the Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for use in assessing Alzheimers dis...
FDA posts a transcript from a 10/27 CDRH public meeting on reauthorizing the Medical Device User Fee Act program that outlined agency-sought increased...
FDA says it is accepting proposals to assess the impact of extended-infusion beta-lactam antibacterial drugs on the development of beta-lactam resista...
FDA grants AlloMek Therapeutics an orphan-drug designation for its macrocyclic MEK kinase inhibitor, CIP-137401, for treating neurofibromatosis Type 1...