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QRxPharma Moxduo FDA Advisory Committee

04/22/2014 - 08:00
04/22/2014 - 17:00

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April 22, 2014: Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
Center Date Time Location
CDER April 22, 2014 8:00 a.m. to 5:00 p.m.
FDA White Oak Campus
Building 31
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
Agenda

Durata Dalbavancin FDA Advisory Committee Meeting

03/31/2014 - 08:00
03/31/2014 - 17:00

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March 31, 2014: Anti-Infective Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER March 31, 2014 8:00 a.m. to 5:00 p.m. FDA White Oak Campus
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Source: http://www.biotechnologyevents.com/node/8542

Nektar Therapeutics Naloxegol Advisory Committee Meeting

06/11/2014 - 08:00
06/12/2014 - 17:00

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AstraZeneca and Nektar Therapeutics have been informed by the U.S. Food and Drug Administration that the Anesthetic and Analgesic Drug Products Advisory Committee (the “Advisory Committee”) meeting being convened to review the mu opioid antagonists being developed for opioid induced constipation, including naloxegol, is now tentatively scheduled for June 11-12, 2014. The date and agenda for the Advisory Committee will not be definitive until publication in the Federal Register.
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http://www.biotechnologyevents.com/node/8518

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Cubist tedizolid Advisory Committee Meeting

03/31/2014 - 08:00
03/31/2014 - 17:00

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FDA Advisory Committee Unanimously Recommends Approval of Cubist’s SIVEXTRO™ (Tedizolid Phosphate) as Treatment for Serious Skin Infections
31 Mar

Novartis - serelaxin - Advisory Committee Meeeting

03/27/2014 - 08:00
03/27/2014 - 17:00

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March 27, 2014 22:08 CET

Novartis to work with FDA on path forward for RLX030 for acute heart failure following Advisory Committee outcome

Advisory Committee members voted against RLX030 for the treatment of acute heart failure (AHF)[1]

Novartis believes RLX030 has the potential to be an important treatment for AHF, a disease with lower survival rates than many advanced cancers or a heart attack

Second phase III study RELAX-AHF-2 started enrolment in September 2013 using mortality as primary endpoint

The Medicine Company - Cangrelor - Advisory Committee Meeting

02/12/2014 - 08:00
02/12/2014 - 17:00

February 12, 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER February 12, 2014 8:00 a.m. to 5:00 p.m. FDA White Oak Campus

Agenda

MannKind Afreeza Advisory Committee Meeting

04/01/2014 - 08:00

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MannKind Announces Tentative Date of FDA Advisory Committee Review of AFREZZA

Endocrinologic and Metabolic Drugs Advisory Committee Meeting Tentatively Scheduled for April 1, 2014

Janssen Pharmaceuticals Rivaroxaban Advisory Committee Meeting

01/16/2014 - 08:00
01/16/2014 - 17:00

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January 16, 2014

FDA Advisory Committee Recommends Against Approval of the Use of Oral Anticoagulant XARELTO® to Reduce the Risk of Thrombotic Cardiovascular Events in Patients with Acute Coronary Syndrome

Merck vorapaxar Advisory Committee Meeting

01/15/2014 - 08:00
01/15/2014 - 17:30

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Merck Statement on FDA Advisory Committee for Vorapaxar, Merck’s Investigational Antiplatelet Medicine

Wednesday, January 15, 2014 6:59 pm EST

Exact Sciences - Cologuard - Medical Devices Advisory Committee Meeting

03/27/2014 - 08:00
03/27/2014 - 17:00

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EXACT SCIENCES ANNOUNCES FDA ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS APPROVAL OF COLOGUARD

First of its Kind Stool-based DNA Screening Test for Colorectal Cancer

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