Biotechnology Events


Novartis biosimilar filgrastim PDUFA FDA Advisory Committee

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


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


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

Basilea/Astellas Pharmaceutica Isavuconazole FDA Advisory Committee

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


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


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


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


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

Celgene Apremilast PDUFA

09/23/2014 - 00:00


U.S. PDUFA goal date for OTEZLA® in moderate-to-severe psoriasis is September 23
Source: press release, 7/24/14.


Pfizer - CHANTIX FDA Advisory and Safety Meeting

10/16/2014 - 08:00
10/16/2014 - 17:00


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

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


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


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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