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Sarepta Therapeutics Eteplirsen FDA Advisory Committee Meeting

04/25/2016 - 08:00
04/25/2016 - 16:30

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Sarepta Therapeutics Announces FDA Advisory Committee Meeting to Review Eteplirsen as a Treatment for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
--Advisory Committee Meeting Rescheduled for April 25, 2016--
--PDUFA date for eteplirsen is May 26, 2016--

Clovis Oncology Rociletinib FDA Advisory Committee Meeting

04/12/2016 - 07:00
04/12/2016 - 16:00

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CLOVIS ONCOLOGY ANNOUNCES ROCILETINIB NEW DRUG APPLICATION SCHEDULED FOR PRESENTATION AT UPCOMING FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING

ACADIA Pharmaceuticals Nuplazid FDA Advisory Committee Meeting

03/29/2016 - 08:00
03/29/2016 - 16:00

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ACADIA Pharmaceuticals Announces FDA Advisory Committee Meeting to Review NUPLAZID™ (Pimavanserin) for the Treatment of Parkinson’s Disease Psychosis
Advisory Committee Meeting Scheduled for March 29, 2016

Intercept Pharmaceuticals Obeticholic Acid FDA Advisory Committee Meeting

04/07/2016 - 08:30
04/07/2016 - 17:00

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FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC

Teva reslizumab FDA Advisory Committee Meeting

12/09/2015 - 08:00
12/09/2015 - 17:00

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December 9, 2015: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement
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Center Date Time Location
CDER December 9, 2015
8:00 a.m. to 5:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland

Agenda

Merck ezetimibe/simvastatin Advisory Committee Meeting

12/14/2015 - 08:00
12/14/2015 - 17:00

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December 14, 2015: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
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Center Date Time Location
CDER December 14, 2015 8:00 a.m. to 5:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland
Agenda

BioMarin Pharmaceutical Drisapersen FDA Advisory Committee

11/24/2015 - 08:30
11/24/2015 - 16:30

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BioMarin Announces FDA Advisory Committee to Review Drisapersen for Treatment of Patients With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

Advisory Committee Meeting Scheduled for November 24, 2015

Dyax Corporation Necitumumab FDA Advisory Committee Meeting

07/09/2015 - 08:00
07/09/2015 - 17:00

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July 9, 2015: Oncologic Drugs Advisory Committee Meeting Announcement

Center Date Time Location
CDER July 9, 2015
8:00 a.m. to 12:30 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland
Agenda

Amgen Evolocumab FDA Advisory Committee Meeting

06/10/2015 - 08:00
06/10/2015 - 17:00

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June 10, 2015: Endocrinologic and Metabolic Drugs Advisory Committee Meeting

Center Date Time Location
CDER June 10, 2015 8:00 a.m. to 5:00 p.m.
Hilton Washington DC North/Gaithersburg
The Grand Ballroom
620 Perry Parkway
Gaithersburg, Maryland
Agenda

Regeneron Alirocumab injection FDA Advisory Committee Meeting

06/09/2015 - 08:00
06/09/2015 - 17:00

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Trading in Regeneron Common Stock Halted
Advisory Committee of the U.S. Food and Drug Administration Reviewing Praluent® (alirocumab) Injection Biologics License Application
TARRYTOWN, N.Y., June 9, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that NASDAQ has halted trading of the company's common stock. The Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is meeting today to discuss the company's Biologics License Application (BLA) for Praluent® (alirocumab) Injection.
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