Cardiome Pharma Corp.
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Latest From Cardiome Pharma Corp.
Advanz Gets European Heft, Portfolio Assets In Correvio Buyout
Deal Snapshot: Building portfolio and commercial infrastructure in Europe, Advanz gets both at a modest price in acquiring Correvio.
Keeping Track Of The US FDA's Final Novel Approvals, CRLs Of 2019
The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.
Brinavess Rejected By Advisory Cmte., Leaving US FDA To Mull Lifting Clinical Hold On Correvio's AFib Drug
Cardiovascular and Renal Drugs Advisory Committee voted 11-2 against approval for Correvio's atrial fibrillation drug Brinavess over cardiovascular safety concerns; the agency would have to lift the long-standing clinical hold on the drug before the company can do any further study in humans.
Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug
Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug; FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.
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