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Rivaroxaban Faces Uphill Battle At FDA Advisory Panel
The third time may not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto...
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FDA Advisory Panel Votes In Favor Of Approval For Merck’s Vorapaxar
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché might have been...
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FDA Panel Once Again Rejects New Indication For Rivaroxaban
The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto...
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FDA Reviewers Deliver Split Opinion On The Medicines Company’s Cangrelor
FDA reviewers presented two dramatically different views of The Medicines Company’s investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even...
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FDA Reviewers Recommend Against Approval For Novartis Heart Failure Drug
Ahead of an important advisory panel FDA reviewers have recommended against approval of a novel drug for acute heart failure from Novartis. The once highly-promising drug, which received a...
View ArticleExpect Intellectual Fireworks At FDA Advisory Panel On Ezetimibe
You can expect a lot of high-powered intellectual fireworks at next Monday’s FDA advisory panel considering Merck’s application to upgrade the indications for Vytorin and Zetia. Both brands contain the...
View ArticleFDA Panel Turns Down Expanded Indication For Ezetimibe
An FDA advisory panel on Monday voted 10-5 against an expanded indication for Merck’s ezetimibe (Vytorin, Zetia). The current label states that the drugs have not been shown to improve cardiovascular...
View ArticleProminent Cardiologists Decry Tepid Support For Empagliflozin By...
At the FDA advisory panel empagliflozin enjoyed strong support from the cardiologists and statisticians but not from the endocrinologists. An FDA advisory panel last week turned out to be a much...
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