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Latest US Food and Drug Administration Stories

2011-02-02 15:49:00

Contrave Disallowed Pending Further Large-Scale Testing SILVER SPRING, Md., Feb. 2, 2011 /PRNewswire-USNewswire/ -- In its latest blow to obesity medication development efforts, the US Food and Drug Administration (FDA) yesterday notified Orexigen Therapeutics that it would need to conduct an extremely large-scale study of the long-term cardiovascular effects of its drug, Contrave, before approval could be considered. The economics of such a trial make it extremely unlikely that it can be...

2011-01-27 15:05:00

SAN DIEGO, Jan. 27, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today a reduction of its US workforce of approximately 25%, or 66 employees. As a result of the workforce reduction, which Arena plans to complete around March 28, 2011, the company expects to incur restructuring charges, primarily in the first quarter of 2011, of approximately $3.8 million in connection with one-time employee termination costs. Arena expects the reduction to decrease annualized...

2011-01-20 06:00:00

PRINCETON, N.J., Jan. 20, 2011 /PRNewswire/ -- Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax(TM) for the prevention of ricin intoxication. RiVax(TM) is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals. The US Orphan...

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2010-12-31 06:30:00

Two American companies broke new ground this year by gaining regulatory approval to begin the first experiments using embryonic stem cells on people suffering from spinal cord injuries and blindness. The use of the cells, which have been hotly debated for years, can transform into nearly any cell in the human body, which could lead to finding ways to eliminate such ailments as Parkinson's disease, diabetes, heart disease, paralysis, and may even help fight aging. As scientists find ways to...

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2010-12-29 06:15:00

A US food safety agency warned consumers on Monday against eating alfalfa sprouts and spicy sprouts (a mixture of three types of sprouts) from Tiny Greens Organic Farm in Urbana, Illinois, after reports surfaced that the foods were tainted with salmonella, possibly behind the 89 cases found throughout the Midwest. USA Today received a call from Tiny Greens Organic Farm owner Bill Bagby on Monday evening. Bagby, who was stranded at a family reunion in North Carolina, told USA Today that the...

2010-12-22 06:30:00

SAN DIEGO and WOODCLIFF LAKE, N.J., Dec. 22, 2010 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA). "The meeting discussions reinforce our position that we have a path forward to seek FDA approval of lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "Based on guidance we have received...

2010-12-21 17:00:00

SAN DIEGO, Dec. 21, 2010 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that Jack Lief, Arena's President and Chief Executive Officer, will host a conference call and webcast tomorrow, Wednesday, December 22, 2010, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to provide an update following the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA). The conference call may be...

2010-12-16 19:59:00

WILMINGTON, Del., Dec. 16, 2010 /PRNewswire/ -- AstraZeneca (NYSE: AZN) announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for ticagrelor (BRILINTA(TM)). (Logo: http://photos.prnewswire.com/prnh/20091027/PH99766LOGO ) In the CRL, the FDA requested additional analyses of the PLATO data. The agency did not request that additional studies, including clinical studies, be conducted as a prerequisite...

2010-12-08 15:01:00

SAN DIEGO, Dec. 8, 2010 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA) has cleared for marketing the Prodesse ProAdeno(TM)+ assay, a multiplex real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of human adenovirus. "FDA clearance of our ProAdeno+ assay adds to the Prodesse portfolio of molecular tests for respiratory infectious diseases," said Eric Tardif,...

2010-12-02 14:16:00

WILMINGTON, Del., Dec. 2, 2010 /PRNewswire/ -- AstraZeneca (NYSE: AZN) today announced the outcome of the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee meeting to discuss the New Drug Application (NDA) for AstraZeneca's investigational drug, vandetanib, for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer (MTC). (Logo: http://photos.prnewswire.com/prnh/20091027/PH99766LOGO ) The Advisory...


Word of the Day
glogg
  • Scandinavian punch made of claret and aquavit with spices and raisins and orange peel and sugar.
This word comes from the Swedish 'glogg,' which is an alteration of 'glodgat,' mulled (wine).
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