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Pfizer - CHANTIX FDA Advisory and Safety Meeting

10/16/2014 - 08:00
10/16/2014 - 17:00

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October 16, 2014: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Center Date Time Location
CDER October 16, 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

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

Novartis - secukinumab - Advisory Committee Meeting

10/20/2014 - 08:00
10/20/2014 - 17:00

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October 20, 2014: Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER October 20, 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

Novartis - liraglutide - Advisory Committee Meeting

09/11/2014 - 08:00
09/11/2014 - 17:00

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September 11, 2014: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER September 11, 2014 8:00 a.m. to 5:00 p.m. Marriott Inn and Conference Center
University of Maryland University College (UMUC), Potomac Ballroom
3501 University Blvd. East
Hyattsville, Maryland

Agenda

Actavis plc nebivolol/valsartan FDA Advisory Committee Meeting

09/09/2014 - 12:00
09/09/2014 - 17:00

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September 9, 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER September 9, 2014 12 noon 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

Baxter/Halozyme HyQvia FDA Advisory Committee

07/31/2014 - 08:00
07/31/2014 - 17:00

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FDA Advisory Committee Panel Provides Favorable Recommendation on Baxter's HyQvia for Primary Immunodeficiency

Progenics Pharmaceuticals Relistor FDA Advisory Meeting

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

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June 11, 2014

Progenics Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee to Consider and Provide Recommendations Regarding Peripherally-Acting Opioid Receptor Antagonists

TARRYTOWN, N.Y., June 11, 2014 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced that NASDAQ has halted trading of the company's common stock.

AstraZeneca Olaparib FDA Advisory Committee

06/25/2014 - 08:00
06/25/2014 - 15:30

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June 25, 2014: Oncologic Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER June 25, 2014 8:00 a.m. to 3:30 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

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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