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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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Repros Enclomiphene FDA Advisory Committee Meeting

11/03/2015 - 08:30
11/03/2015 - 17:00

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Repros Announces Date of FDA Advisory Committee Review of NDA

Vertex Pharmaceuticals, Inc. Lumacaftor / KALYDECO (Ivacaftor) FDA Advisory Committee

05/12/2015 - 08:00
05/12/2015 - 16:00

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May 12, 2015: Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

Center Date Time Location
CDER May 12, 2015
8:00 a.m. to 4:00 p.m.
Hilton Washington DC North/
Gaithersburg, The Ballrooms
620 Perry Pkwy.
Gaithersburg, Maryland 20877
Agenda

AstraZeneca / Teva - Saxagliptin and alogliptin (DPP4) inhibitors - CVOT

04/14/2015 - 07:30
04/14/2015 - 17:15

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April 14, 2015: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Center Date Time Location
CDER April 14, 2015 7:30 a.m. to 5:15 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland
Agenda

The Medicine Company Cangrelor FDA Advisory Committee Meeting

04/15/2015 - 08:00
04/15/2015 - 16:00

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April 15, 2015: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement

Center Date Time Location
CDER April 15, 2015
8:00 a.m. to 4:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland
Agenda

KYTHERA Biopharmaceuticals ATX-101 FDA Advisory Committee Meeting

03/09/2015 - 08:30
03/09/2015 - 14:00

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KYTHERA Biopharmaceuticals Announces Date of FDA Advisory Committee Review of ATX-101 for the Treatment of Submental Fullness
January 23, 2015

Westlake Village, Calif., January 23, 2015 – KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced the Dermatology and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review KYTHERA’s New Drug Application (NDA) for ATX-101 (deoxycholic acid) for improvement in the appearance of moderate to severe submental fullness in a half-day meeting on the morning of March 9, 2015.

Theravance Breo/Elipta FDA Advisory Committee Meeting

03/19/2015 - 08:30
03/19/2015 - 18:00

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Theravance Announces FDA Advisory Committee to Review BREO(R) ELLIPTA(R) (FF/VI) for Asthma

Novartis biosimilar filgrastim PDUFA FDA Advisory Committee

01/07/2015 - 08:00
01/07/2015 - 17:00

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Sandoz biosimilar filgrastim recommended for approval by FDA Oncologic Drugs Advisory Committee

 Oncologic Drugs Advisory Committee (ODAC) votes in favor of recommending biosimilar filgrastim for approval in the US

 Biosimilar filgrastim recommended to be approved for use in all requested indications

 Committee’s recommendation based on review of extensive data from analytical, non-clinical, clinical studies and post-marketing pharmacovigilance

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