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Cempra, Inc. Solithromycin CAP FDA Advisory Committee Meeting

11/04/2016 - 08:00
11/04/2016 - 18:00

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Cempra to Present Solithromycin at FDA Antimicrobial Drugs Advisory Committee Meeting on November 4, 2016
FDA currently reviewing NDAs for IV and oral solithromycin for community-acquired bacterial pneumonia, with PDUFA dates in late December

Allergan/Serenity Pharmaceuticals, LLC Desmopressin FDA Advisory Committee Meeting

10/19/2016 - 08:15
10/19/2016 - 17:00

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October 19, 2016: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee

Center Date Time Location
CDER October 19, 2016 8:15 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

The committee will discuss the efficacy and safety of new drug application (NDA) 201656 (desmopressin), 0.75 mcg/0.1 mL and 1.5 mcg/0.1 mL nasal spray, submitted by Serenity Pharmaceuticals, LLC, for the proposed treatment of adult onset nocturia.

Meeting Materials

Egalet U.S. morphine sulfate extended-release tablets Advisory Committee Meeting

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

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Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent ARYMO™ ER (Morphine Sulfate) and Reports Second Quarter 2016 Financial Results

--Committees voted that if approved ARYMO ER should be labeled as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse--

--Company to discuss results of the FDA Advisory Committees meeting and the financial results during conference call today at 5:15 PM EDT--

Aug 4, 2016

Valeant Pharmaceuticals brodalumab injection FDA Advisory Committee Meeting

07/19/2016 - 08:00
07/19/2016 - 17:00

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July 19, 2016: Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement

Center Date Time Location
CDER July 19, 2016
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

Amgen ABP 501 FDA Advisory Committee Meeting

07/12/2016 - 07:30
07/12/2016 - 17:00

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Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab

THOUSAND OAKS, Calif., June 13, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Company's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira® (adalimumab).

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

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