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
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)
3501 University Blvd.
East, Hyattsville, Maryland 20783
Astellas Announces FDA Anti-Infective Drugs Advisory Committee Recommends Approval of CRESEMBA® (isavuconazonium) for Treatment of Invasive Aspergillosis and Mucormycosis
Jan 22, 2015
Synta Announces FDA’s Oncologic Drugs Advisory Committee to Discuss Pediatric Uses for Ganetespib
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
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
U.S. PDUFA goal date for OTEZLA® in moderate-to-severe psoriasis is September 23
Source: press release, 7/24/14. http://ir.celgene.com/releasedetail.cfm?ReleaseID=861748
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
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.
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
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.