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Latest From Michael Cipriano
Brinavess Rejected By Advisory Cmte., Leaving US FDA To Mull Lifting Clinical Hold On Correvio's AFib Drug
Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News
The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.
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.
Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings
Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.
The Senate HELP Committee votes 18-5 to send Stephen Hahn's nomination to head the US FDA to the full chamber, although a few senators raised concerns over Hahn's responses to questions about e-cigarettes during his confirmation hearing.
The latest drug development news and highlights from our US FDA Performance Tracker.