Latest REDUCE-IT Results Bolster Case For Amarin's Vascepa Fish Oil Pill
Data may pave way for inclusion in heart disease treatment guidelines, ACC spokesperson says.
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An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA
The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.
Finance Watch: Amarin Raises Cash To Boost Vascepa Marketing Under Soon-To-Be Expanded Label
Public Company Edition: Two months before the deadline for the company's sNDA, the US FDA has not indicated it will hold an advisory committee meeting for the triglyceride-lowering drug. Also, Seattle Genetics raises $575m, Atara and Ra bring in $150m each and Cara completes $145.5m offering.
Keeping Track: A Busy Week For Regenerative Medicine, A Surprise Priority Review For Vascepa, And Tazemetostat Aims For Accelerated Approval
The latest drug development news and highlights from our US FDA Performance Tracker.