Tag: approval

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CORRECTING and REPLACING CAPTION FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure and Early Use of Impella RP Leads to Higher Survival

Newsemia
DETROIT–(BUSINESS WIRE)–Physicians who followed the FDA’s approved protocol for Impella RP use achieved 72% patient survival and 88% native heart recovery. Source link...
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Emmaus withdraws European application for sickle cell drug that got US approval

Newsemia
The company said it would withdraw the application for Xyndari after the EMA’s Committee for Medicinal Products for Human Use followed a negative opinion from...

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