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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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October 30, 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement

Center Date Time Location
CDER October 30, 2014 8:00 a.m. to 5:30 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

Celgene Apremilast PDUFA

09/23/2014 - 00:00

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U.S. PDUFA goal date for OTEZLA® in moderate-to-severe psoriasis is September 23
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Source: press release, 7/24/14. http://ir.celgene.com/releasedetail.cfm?ReleaseID=861748

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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 20:59 CET

Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe plaque psoriasis

Biologics License Application (BLA) for secukinumab, a "first-in-class" IL-17A inhibitor, is currently under FDA review with an anticipated action date in early 2015

FDA Advisory Committee recommendation based on efficacy and safety outcomes of 10 Phase II/III clinical studies of secukinumab in moderate-to-severe plaque psoriasis

Novo Nordisk - liraglutide - Advisory Committee Meeting

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

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Sep 11, 2014
Saxenda® for the treatment of obesity receives positive 14-1 vote in favour of approval from FDA Advisory Committee
Bagsværd, Denmark, 11 September 2014 - Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the United States Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Application (NDA) for Saxenda®, the intended brand name for liraglutide 3 mg, a once-daily human GLP-1 analogue for the treatment of obesity.
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Actavis plc nebivolol/valsartan FDA Advisory Committee Meeting

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

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FDA Advisory Committee Recommends Against Approval of Actavis' Nebivolol/Valsartan Fixed-Dose Combination NDA for Treatment of Hypertension

09.09.2014 | Investors

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

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