Category archives for: drug applications

Eisai Announces Extension of FDA Review of Drug Application for Investigational Agent Eribulin Mesylate

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Aug 30, 2010 – Eisai Inc.
announced today that it has received notification from the U.S.
Food and Drug Administration (FDA) that the agency expects to
complete priority review of the eribulin mesylate New…

Jazz Pharmaceuticals Provides Update on FDA Advisory Committee Meeting For JZP-6 (Sodium Oxybate) in Fibromyalgia

PALO ALTO, Calif., Aug. 20 /PRNewswire-FirstCall/ — Jazz
Pharmaceuticals, Inc. announced today that the Joint
Advisory Committee of the U.S. Food and Drug Administration (FDA),
including the Arthritis Advisory Committee and the Drug Safety…

EpiCept Corporation Receives Refusal to File Letter from US FDA on Ceplene New Drug Application

TARRYTOWN, N.Y.–(BUSINESS WIRE)–Aug 23, 2010 – Regulatory
News:
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange:
EPCT) today announced that it received a refusal to file letter
from the U.S. Food and Drug Administration (FDA) on…

Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for Benlysta (belimumab) as a Potential Treatment for Systemic Lupus Erythematosus

ROCKVILLE, Md.–(BUSINESS WIRE)–Aug 19, 2010 – Human Genome
Sciences, Inc. and GlaxoSmithKline PLC (GSK) today
announced that the U.S. Food and Drug Administration (FDA) has
granted a priority review designation to Benlysta (belimumab)
as a…

Ipilimumab Receives FDA Priority Review Designation for Adult Patients with Previously Treated Advanced Melanoma

PRINCETON, N.J.–(BUSINESS WIRE)–Aug 18, 2010 – Bristol-Myers Squibb Company today announced that
the U.S. Food and Drug Administration (FDA) has accepted, for
filing and review, the Biologics License Application (BLA) for
ipilimumab for the…

Ezogabine, an Investigational Anti-Epileptic Drug, Receives Positive Vote from FDA Advisory Committee

RESEARCH TRIANGLE PARK, N.C. and ALISO VIEJO, Calif., Aug. 11
/PRNewswire-FirstCall/ — GlaxoSmithKline and Valeant
Pharmaceuticals International announced today that a
U.S. Food and Drug Administration (FDA) advisory committee voted
unanimously…

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