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FDA Advisory Committees

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Latest From Advisory Committees

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.
Advisory Committees Cardiovascular

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.

Advisory Committees Cardiovascular

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Lynparza, Keytruda Supplemental Indications Face US FDA Panel Review

AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.

Advisory Committees Drug Review

A Year Of Reconsiderations For US FDA Advisory Committees

Correvio’s anti-arrhythmic vernakalant is returning to an advisory committee a dozen years after its first review, continuing a recent pattern of return visits for applications – and 12 years isn’t even close to the longest long back for US FDA panel in 2019.

Advisory Committees Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review
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