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Novartis resubmits its NDA for inclisiran, resolving FDA manufacturing facility questions raised in a complete response letter.[ Price : $8.95]
FDA says a Quidel recall of 18,365 Lyra SARS-CoV-2 assay kits due to the potential for false-negative results is Class 1.[ Price : $8.95]
FDA clears an AliveCor 510(k) to use its KardiaMobile 6L device to calculate patients QTc interval.[ Price : $8.95]
Catalyst Pharmaceuticals asks FDA to apply restrictions to the approval of any NDA for an amifampridine drug product intended to t...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Beovu (brolucizumab-dbll), ...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Acacia Pharmas Barhemsys (a...[ Price : $8.95]
Federal Register notice: FDA posts a final guidance entitled Unique Device Identification System: Form and Content of the Unique D...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pulmonx Corp.s Zephyr Endob...