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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

Actavis Ceftazidime-Avibactam Advisory Committee

12/05/2014 - 08:00
12/05/2014 - 16:30

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December 5, 2014: Anti-Infective Drugs Advisory Committee Meeting Announcement

Center Date Time Location
CDER December 5, 2014 8:00 a.m. to 4:30 p.m.
The Marriott Inn and Conference Center
University of Maryland
University College (UMUC)
The Ballroom
3501 University Blvd.
East, Hyattsville, Maryland 20783
Agenda

Basilea/Astellas Pharmaceutica Isavuconazole FDA Advisory Committee

01/22/2015 - 08:00
01/22/2015 - 17:00

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Astellas Announces FDA Anti-Infective Drugs Advisory Committee Recommends Approval of CRESEMBA® (isavuconazonium) for Treatment of Invasive Aspergillosis and Mucormycosis

Jan 22, 2015

Synta Pharmaceuticals Ganetespib FDA Advisory Subcommittee

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

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Synta Announces FDA’s Oncologic Drugs Advisory Committee to Discuss Pediatric Uses for Ganetespib

Vertex Pharmaceuticals Ivacaftor oral tablets Advisory Committee Meeting

10/21/2014 - 08:30

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October 21, 2014
FDA Advisory Committee Recommends Approval of KALYDECO® (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation

Daiichi Sankyo edoxaban FDA Advisory Committee

10/30/2014 - 08:00
10/30/2014 - 17:30

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U.S. FDA Cardiovascular and Renal Drugs Advisory Committee Makes Recommendation on Daiichi Sankyo’s Once-Daily SAVAYSA™ (edoxaban) for the Reduction in Risk of Stroke and Systemic Embolic Events in Patients with Non-Valvular Atrial Fibrillation

・ Committee votes 9 to 1 to recommend approval of once-daily SAVAYSA for the reduc-tion in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF)

・ Daiichi Sankyo to work with the FDA during continued review of its New Drug Appli-cation

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