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FDA Accepts Eisai’s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration has accepted Eisai’s Supplemental Biologics License Application for monthly lecanemab-irmb intravenous maintenance dosing.

FDA Accepts Eisai’s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Read More »

DeepQure receives IDE Approval from FDA for its EFS study to treat Resistant Hypertension with its Extravascular Renal Denervation Technology (HyperQure™)

DeepQure, a Seoul based medical device company with a novel, extravascular solution for renal denervation, announced initiation of its Early Feasibility Study for the HyperQure™ system following FDA IDE approval.

DeepQure receives IDE Approval from FDA for its EFS study to treat Resistant Hypertension with its Extravascular Renal Denervation Technology (HyperQure™) Read More »

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